The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Agility Lp Total Ankle Prosthesis.
| Device ID | K053569 |
| 510k Number | K053569 |
| Device Name: | AGILITY LP TOTAL ANKLE PROSTHESIS |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-22 |
| Decision Date | 2006-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295035473 | K053569 | 000 |
| 10603295035176 | K053569 | 000 |
| 10603295035206 | K053569 | 000 |
| 10603295035237 | K053569 | 000 |
| 10603295035268 | K053569 | 000 |
| 10603295035299 | K053569 | 000 |
| 10603295035329 | K053569 | 000 |
| 10603295035350 | K053569 | 000 |
| 10603295035381 | K053569 | 000 |
| 10603295035411 | K053569 | 000 |
| 10603295035442 | K053569 | 000 |
| 10603295035145 | K053569 | 000 |