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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
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- 3.5MM Square Tip, 13 CM, Total Ankle Tibia Drill FDA UDI
- Model / Reference
- P10-842-35SQ FDA UDI
- Description
- 3.5MM Square Tip, 13 CM, Total Ankle Tibia Drill FDA UDI
Identifiers
- Catalog Number
- P10-842-35SQ FDA UDI
- Primary DI / UDI-DI
- 00889795132321 FDA UDI
- 510(k) Number
- K210390 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Cannulated surgical drill bit, single-use 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
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
No
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 Total Ankle Replacement System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cannulated surgical drill bit, single-use.
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Cleared under the same submission
K210390 also covers:
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
- APEX 3D Total Ankle Replacement System — Paragon 28
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI b532e682-75d6-4ec6-990b-bd6b928b2831 35 fields · synced May 30, 2026