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APEX 3D Total Ankle Replacement System
FDA UDIClass II (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- APEX 3D Total Ankle Replacement System FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- APEX 3D-PS Total Ankle Replacement System, Talus Impaction Handle, Screw FDA UDI
- Model / Reference
- P10-952-TL00-05 FDA UDI
- Description
- APEX 3D-PS Total Ankle Replacement System, Talus Impaction Handle, Screw FDA UDI
Identifiers
- Catalog Number
- P10-952-TL00-05 FDA UDI
- Primary DI / UDI-DI
- 00889795121448 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3110 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Surgical instrument handle, non-torque-limiting
APEX 3D Total Ankle Replacement System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument handle, non-torque-limiting.
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- CUSTOM U JOINT DRIVER — Zimmer, Inc. · Class I
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
- Paragon 28
Sources (1)
- FDA UDI 8a482a47-84a7-4418-822d-5658604defa5 34 fields · synced May 29, 2026