Identity
- Trade Name
- AGILITY FDA UDI
- Generic Name
- Ankle prosthesis bearing FDA UDI
- Device Name
- AGILITY LP TOTAL ANKLE SYSTEM +1 POLY INSERT SIZE 4 FDA UDI
- Model / Reference
- 1404-34-010 FDA UDI
- Description
- AGILITY LP TOTAL ANKLE SYSTEM +1 POLY INSERT SIZE 4 FDA UDI
Identifiers
- Catalog Number
- 140434010 FDA UDI
- Primary DI / UDI-DI
- 10603295035749 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Ankle prosthesis bearing 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Ankle prosthesis bearing
Agility by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ankle prosthesis bearing.
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- Kinos Total Ankle Replacement — Restor3D · Class II
- Hintermann Series H3 — Dt Medtech, LLC · Class III
- Hintermann Series H2 — Dt Medtech, LLC · Class II
- Hintermann Series H2 — Dt Medtech, LLC · Class II
- Kinos Total Ankle Replacement — Restor3D · Class II
- Hintermann Series H2 — Vilex, Inc. · Class II
Cleared under the same submission
K053569 also covers:
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
K122395 also covers:
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
- AGILITY — DEPUY ORTHOPAEDICS, INC.
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 |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI d21a1a69-7062-4533-a64c-d59f822ff156 36 fields · synced Jun 8, 2026