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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
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Total Ankle, Instrument, Poly Insertion Tool, Gen II, SS FDA UDI
- Model / Reference
- P10-851-PT02 FDA UDI
- Description
- Total Ankle, Instrument, Poly Insertion Tool, Gen II, SS FDA UDI
Identifiers
- Catalog Number
- P10-851-PT02 FDA UDI
- Primary DI / UDI-DI
- 00889795128577 FDA UDI
- 510(k) Number
- K210390 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable 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
Category: Orthopaedic inorganic implant inserter/extractor, reusable
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 Orthopaedic inorganic implant inserter/extractor, reusable.
- Omnia Medical Golden Spike — Omnia Medical · Class I
- Calibrate — ALPHATEC SPINE, INC. · Class II
- PAR 5 RING-LOC — Biomet Orthopedics, Inc. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
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 0f4b9ea2-4717-4c05-8369-c04b786def9d 35 fields · synced May 30, 2026