The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Cap Resurfacing Replacement Shoulder.
| Device ID | K031971 |
| 510k Number | K031971 |
| Device Name: | GLOBAL CAP RESURFACING REPLACEMENT SHOULDER |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-26 |
| Decision Date | 2003-09-24 |
| Summary: | summary |