The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Attune Total Knee System.
| Device ID | K103756 |
| 510k Number | K103756 |
| Device Name: | DEPUY ATTUNE TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Nancy Friddle |
| Correspondent | Nancy Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295056706 | K103756 | 000 |
| 10603295056621 | K103756 | 000 |
| 10603295056638 | K103756 | 000 |
| 10603295056645 | K103756 | 000 |
| 10603295056652 | K103756 | 000 |
| 10603295056669 | K103756 | 000 |
| 10603295056676 | K103756 | 000 |
| 10603295056683 | K103756 | 000 |
| 10603295056690 | K103756 | 000 |
| 10603295056614 | K103756 | 000 |