Identity
- Trade Name
- OrthoMesh FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- 2.0MM RESORBABLE CORTEX SCREW 6MM FOR ORTHOMESH-STERILE FDA UDI
- Model / Reference
- 804.006.02S FDA UDI
- Description
- 2.0MM RESORBABLE CORTEX SCREW 6MM FOR ORTHOMESH-STERILE FDA UDI
Identifiers
- Catalog Number
- 80400602S FDA UDI
- Primary DI / UDI-DI
- 20886982255959 FDA UDI
- 510(k) Number
- K073115 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Bioabsorbable orthopaedic bone screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bioabsorbable orthopaedic bone screw
OrthoMesh by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bioabsorbable orthopaedic bone screw.
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- MILAGRO — Medos International Sàrl · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synthes
Sources (1)
- FDA UDI 96909c54-780d-4633-8352-a6e76dd00d24 37 fields · synced May 30, 2026