OrthoMesh
- Primary DI
- H67980360502S0
- Brand
- OrthoMesh
- Company
- SYNTHES (U.S.A.) LP
- Model
- 803.605.02S
- Catalog number
- 80360502S
- Device description
- 1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE
- Published
- 2015-09-14
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| HRS | PLATE, FIXATION, BONE |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K073115 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20886982255935 | Primary | GS1 | 0 | |
| H67980360502S0 | Secondary | HIBCC | 0 | |
| 80886982255937 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20886982255935 | 20886982255935 |
| 80886982255937 | 80886982255937 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone screw, bioabsorbable | A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 0 | 43 Degrees Celsius | |
| Handling Environment Temperature | 0 | 110 Degrees Fahrenheit | |
| Special Storage Condition, Specify | 0 | 0 | . |
| Storage Environment Temperature | 5 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 41 Degrees Fahrenheit | 77 Degrees Fahrenheit |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)255-2500 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 832637081
- Device count
- 2
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10886982249210 | NA | 60.550.040 | 60550040 | 2017-02-20 |
| 10886982239884 | NA | 530.412 | 530412 | 2016-12-31 |
| 10886982192172 | NA | 329.722 | 329722 | 2017-02-20 |
| 10886982192295 | LC-DCP | 329.918 | 329918 | 2017-02-20 |
| 10886982201461 | NA | 398.56 | 39856 | 2017-02-20 |
| 10886982201478 | NA | 398.58 | 39858 | 2017-02-20 |
| 10705034718040 | NA | 03.620.219 | 03620219 | 2018-10-29 |
| 10705034767802 | VentroFix | 304.832 | 304832 | 2016-12-31 |
| 10705034775418 | NA | 389.296 | 389296 | 2016-12-31 |
| 10705034775425 | NA | 389.297 | 389297 | 2016-12-31 |
| 10705034775432 | NA | 389.298 | 389298 | 2016-12-31 |
| 10705034775449 | NA | 389.299 | 389299 | 2016-12-31 |
| 10705034798455 | NA | 690.038 | 690038 | 2016-12-31 |
| 10887587039893 | NA | 338.761 | 338761 | 2016-12-31 |
| 10886982338778 | MAXFRAME | 1100022-01 | 110002201 | 2024-02-05 |
| 10886982338570 | MAXFRAME | 1100011-01 | 110001101 | 2022-04-26 |
| 10886982338587 | MAXFRAME | 1100010-01 | 110001001 | 2022-04-26 |
| 10886982338594 | MAXFRAME | 1100012-01 | 110001201 | 2022-04-26 |
| 10886982338600 | MAXFRAME | 1100007-01 | 110000701 | 2022-04-26 |
| 10886982237217 | NA | 510.161 | 510161 | 2019-02-21 |
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