The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Global Total Shoulder.
| Device ID | K905786 |
| 510k Number | K905786 |
| Device Name: | GLOBAL TOTAL SHOULDER |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | David Kotkovetz |
| Correspondent | David Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295007326 | K905786 | 000 |
| 10603295006961 | K905786 | 000 |
| 10603295006985 | K905786 | 000 |
| 10603295007005 | K905786 | 000 |
| 10603295007029 | K905786 | 000 |
| 10603295007043 | K905786 | 000 |
| 10603295007227 | K905786 | 000 |
| 10603295007241 | K905786 | 000 |
| 10603295007265 | K905786 | 000 |
| 10603295007289 | K905786 | 000 |
| 10603295007302 | K905786 | 000 |
| 10603295006947 | K905786 | 000 |