OrthoMesh 80360502S
GUDID H67980360502S0
1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE
SYNTHES (U.S.A.) LP
Orthopaedic bone screw, bioabsorbable| Primary Device ID | H67980360502S0 |
| NIH Device Record Key | 312cc5db-569f-4aeb-9441-634783eee853 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoMesh |
| Version Model Number | 803.605.02S |
| Catalog Number | 80360502S |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20886982255935 [Primary] |
| GS1 | 80886982255937 [Unit of Use] |
| HIBCC | H67980360502S0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073115
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [OrthoMesh]
| H67980400602S0 | 2.0MM RESORBABLE CORTEX SCREW 6MM FOR ORTHOMESH-STERILE |
| H67980360502S0 | 1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE |
Trademark Results [OrthoMesh]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOMESH 77717635 3759211 Live/Registered |
DEPUY SYNTHES, INC. 2009-04-20 |
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