The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Acclaim Total Elbow System.
| Device ID | K060696 |
| 510k Number | K060696 |
| Device Name: | ACCLAIM TOTAL ELBOW SYSTEM |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-16 |
| Decision Date | 2006-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295067672 | K060696 | 000 |
| 10603295067665 | K060696 | 000 |
| 10603295067658 | K060696 | 000 |