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APEX 3D S Total Ankle Replacement System
FDA UDIClass I (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- APEX 3D S Total Ankle Replacement System FDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- Short Stem Tibia, Instrument, Drill Bit Cap D10.5, Tall FDA UDI
- Model / Reference
- P11-854-C10T FDA UDI
- Description
- Short Stem Tibia, Instrument, Drill Bit Cap D10.5, Tall FDA UDI
Identifiers
- Catalog Number
- P11-854-C10T FDA UDI
- Primary DI / UDI-DI
- 00889795136879 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Cannulated surgical drill bit, single-use 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
Yes
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
Category: Cannulated surgical drill bit, single-use
APEX 3D S 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 ce76e030-2088-4a43-bd86-dcc5ffd91fbc 34 fields · synced Jun 8, 2026