OrthoMesh
- Primary DI
- H67985171197S0
- Brand
- OrthoMesh
- Company
- Synthes GmbH
- Model
- 851.711.97S
- Catalog number
- 85171197S
- Device description
- ORTHOMESH RESORBABLE STRAIGHT ROW 50MMX50MMX0.5MM-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 |
|---|---|---|---|---|
| 10886982256140 | Primary | GS1 | 0 | |
| H67985171197S0 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10886982256140 | 10886982256140 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic fixation plate, bioabsorbable | A small, implantable sheet of firm material that is attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device is typically used for smaller post-traumatic or pathological orthopaedic fractures (e.g., of the hand or wrist). It may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). |
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
- 486711679
- Device count
- 1
- 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 |
|---|---|---|---|---|
| 10886982239297 | NA | 519.51 | 51951 | 2017-02-20 |
| 10886982195937 | NA | 357.222 | 357222 | 2017-02-20 |
| 10886982238115 | NA | 511.904 | 511904 | 2016-12-31 |
| 10886982239358 | NA | 519.53 | 51953 | 2016-12-31 |
| 10886982249043 | NA | 60.550.011 | 60550011 | 2017-02-20 |
| 10886982249104 | NA | 60.550.016 | 60550016 | 2017-02-20 |
| 10886982249135 | NA | 60.550.020 | 60550020 | 2017-02-20 |
| 10886982249142 | NA | 60.550.021 | 60550021 | 2017-02-20 |
| 10886982254917 | NA | 690.594 | 690594 | 2017-02-20 |
| 10886982362797 | NA | SD03.111.915 | SD03111915 | 2026-08-26 |
| 10886982362803 | NA | SD03.111.916 | SD03111916 | 2026-08-26 |
| 10886982362810 | NA | SD03.111.917 | SD03111917 | 2026-08-26 |
| 10886982362827 | NA | SD03.111.918 | SD03111918 | 2026-08-26 |
| 10886982362834 | NA | SD03.111.919 | SD03111919 | 2026-08-26 |
| 10886982362988 | NA | SD312.030 | SD312030 | 2026-08-26 |
| 10886982362995 | NA | SD312.031 | SD312031 | 2026-08-26 |
| 10886982363008 | NA | SD312.032 | SD312032 | 2026-08-26 |
| 10886982363015 | NA | SD312.033 | SD312033 | 2026-08-26 |
| 10887587078496 | NA | SD03.503.037 | SD03503037 | 2026-08-26 |
| 10887587078595 | NA | SD03.501.444 | SD03501444 | 2026-08-26 |
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| 07901125620940 | Versalock Mini and Micro Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-08-27 |
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