Identity
- Trade Name
- AGILITY FDA UDI
- Generic Name
- Coated ankle talus prosthesis FDA UDI
- Device Name
- AGILITY TOTAL ANKLE SYSTEM REVISION TALAR SIZE 5 CEMENTED FDA UDI
- Model / Reference
- 1555-05-030 FDA UDI
- Description
- AGILITY TOTAL ANKLE SYSTEM REVISION TALAR SIZE 5 CEMENTED FDA UDI
Identifiers
- Catalog Number
- 155505030 FDA UDI
- Primary DI / UDI-DI
- 10603295058618 FDA UDI
- 510(k) Number
- K020541 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Coated ankle talus prosthesis 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: Coated ankle talus prosthesis
Agility by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Hintermann Series — Vilex, Inc. · Class II
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Cleared under the same submission
K020541 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.
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 0a9f73e0-e7d4-44bb-b987-725faf4404a7 36 fields · synced Jun 8, 2026