Identity
- Trade Name
- TruMatch FDA UDI
- Generic Name
- Orthopaedic fixation plate, bioabsorbable FDA UDI
- Device Name
- TRUMATCH GRAFT CAGE-LONG BONE 2.5CM TO 5CM / STERILE FDA UDI
- Model / Reference
- SD900.500S FDA UDI
- Description
- TRUMATCH GRAFT CAGE-LONG BONE 2.5CM TO 5CM / STERILE FDA UDI
Identifiers
- Catalog Number
- SD900500S FDA UDI
- Primary DI / UDI-DI
- 10886982262462 FDA UDI
- 510(k) Number
- K180821 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
MR Safe FDA UDI
Category: Orthopaedic fixation plate, bioabsorbable
TruMatch by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, bioabsorbable.
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- 1.5 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · 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 9e99c25f-c4fc-4707-ab01-d243a59e35a6 37 fields · synced May 29, 2026