The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Agility Ankle Revision Prosthesis.
| Device ID | K020541 |
| 510k Number | K020541 |
| Device Name: | AGILITY ANKLE REVISION PROSTHESIS |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295058625 | K020541 | 000 |
| 10603295058618 | K020541 | 000 |
| 10603295058601 | K020541 | 000 |
| 10603295058595 | K020541 | 000 |
| 10603295058588 | K020541 | 000 |
| 10603295058571 | K020541 | 000 |