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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
- Surgical implant template, reusable FDA UDI
- Device Name
- APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 4, 11mm FDA UDI
- Model / Reference
- P10-930-I411 FDA UDI
- Description
- APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 4, 11mm FDA UDI
Identifiers
- Catalog Number
- P10-930-I411 FDA UDI
- Primary DI / UDI-DI
- 00889795062796 FDA UDI
- 510(k) Number
- K192994 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Surgical implant template, 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Surgical implant template, 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 Surgical implant template, reusable.
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- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Cleared under the same submission
K192994 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 53101aab-1d54-49a5-9eba-a5b52bd4dff4 35 fields · synced May 31, 2026