The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Advantage Extended Humeral Head.
| Device ID | K000575 |
| 510k Number | K000575 |
| Device Name: | GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE 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 | 2000-02-22 |
| Decision Date | 2000-03-10 |