The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Agility Lp Total Ankle Prosthesis.
| Device ID | K122395 |
| 510k Number | K122395 |
| Device Name: | DEPUY 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 | Megan Burns |
| Correspondent | Megan Burns 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 | 2012-08-07 |
| Decision Date | 2012-10-31 |