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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
- Talar Decoupled Resection, Split Shim, +5mm FDA UDI
- Model / Reference
- P10-942-DT15 FDA UDI
- Description
- Talar Decoupled Resection, Split Shim, +5mm FDA UDI
Identifiers
- Catalog Number
- P10-942-DT15 FDA UDI
- Primary DI / UDI-DI
- 00889795063052 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
A comprehensive 2-3 paragraph SEO description written in clear, natural language. The APEX 3D Total Ankle Replacement System is a hand-held surgical instrument designed to aid in the implantation of orthopaedic prostheses.
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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 8bf767f9-80da-42a2-8a3c-58a395e84c72 34 fields · synced Jul 10, 2026