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APEX 3D Total Ankle Replacement System
FDA UDIClass I (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- APEX 3D Total Ankle Replacement System FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Tibial Flat/Flat, Resection Block Size 1 FDA UDI
- Model / Reference
- P10-942-FL11 FDA UDI
- Description
- Tibial Flat/Flat, Resection Block Size 1 FDA UDI
Identifiers
- Catalog Number
- P10-942-FL11 FDA UDI
- Primary DI / UDI-DI
- 00889795063168 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
APEX 3D Total Ankle Replacement System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 769563c0-86e3-45e5-bbbe-f49947dd495d 34 fields · synced May 31, 2026