← Back to catalogue
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 surgical distractor, internal FDA UDI
- Device Name
- APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Tibia Paddle, Constrained FDA UDI
- Model / Reference
- P10-951-P001 FDA UDI
- Description
- APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Tibia Paddle, Constrained FDA UDI
Identifiers
- Catalog Number
- P10-951-P001 FDA UDI
- Primary DI / UDI-DI
- 00889795063717 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical distractor, internal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic surgical distractor, internal
APEX 3D Total Ankle Replacement System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical distractor, internal.
- Sigma — ALPHATEC SPINE, INC. · Class I
- EVEREST Spinal System — K2M, INC. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Regatta — SeaSpine Orthopedics Corporation · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- EIT ALIF Paddle Distractor — EIT Emerging Implant Technologies GmbH · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 24821b4f-3d64-4f36-9c80-840d38a8baab 34 fields · synced Jun 1, 2026