The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Global(tm) Total Shoulder W/dupont Enhanced Uhmwpe.
| Device ID | K914000 |
| 510k Number | K914000 |
| Device Name: | GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | David A Kotkovetz |
| Correspondent | David A 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 | 1991-09-06 |
| Decision Date | 1991-12-04 |