The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Global Ap Shoulder System.
| Device ID | K060874 |
| 510k Number | K060874 |
| Device Name: | DEPUY GLOBAL AP SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-30 |
| Decision Date | 2006-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295005568 | K060874 | 000 |
| 10603295005537 | K060874 | 000 |
| 10603295005506 | K060874 | 000 |
| 10603295005476 | K060874 | 000 |