OrthoMesh 85171197S
GUDID H67985171197S0
ORTHOMESH RESORBABLE STRAIGHT ROW 50MMX50MMX0.5MM-STERILE
Synthes GmbH
Orthopaedic fixation plate, bioabsorbable| Primary Device ID | H67985171197S0 |
| NIH Device Record Key | 35d78d07-323c-469e-9940-ddc08c5cba7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoMesh |
| Version Model Number | 851.711.97S |
| Catalog Number | 85171197S |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| Device Count | 1 |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886982256140 [Primary] |
| HIBCC | H67985171197S0 [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 | 4 |
| Public Version Date | 2022-04-29 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [OrthoMesh]
| H67985171297S0 | ORTHOMESH RESORBABLE STRAIGHT ROW 100MMX100MMX0.5MM-STERILE |
| H67985171197S0 | ORTHOMESH RESORBABLE STRAIGHT ROW 50MMX50MMX0.5MM-STERILE |
Trademark Results [OrthoMesh]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOMESH 77717635 3759211 Live/Registered |
DEPUY SYNTHES, INC. 2009-04-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.