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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 osteotome FDA UDI
- Device Name
- APEX 3D-PS Total Ankle Replacement System, Tibial Osteotome, ARC FDA UDI
- Model / Reference
- P10-901-OS01 FDA UDI
- Description
- APEX 3D-PS Total Ankle Replacement System, Tibial Osteotome, ARC FDA UDI
Identifiers
- Catalog Number
- P10-901-OS01 FDA UDI
- Primary DI / UDI-DI
- 00889795061850 FDA UDI
- FDA Product Code
- HWM FDA UDI
- GMDN Term
- Orthopaedic osteotome 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic osteotome
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 osteotome.
- Stratum Ankle — Medartis Inc. · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- Bone Tamp — SONTEC INSTRUMENTS, INC. · Class I
- Symmetry Lambotte — SYMMETRY SURGICAL INC. · Class I
- gSource — GSOURCE, LLC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- ORTHOMED — ORTHO-MED, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 8b23f03e-32d3-48a1-9ead-590df6f46369 34 fields · synced Jun 8, 2026