The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head.
| Device ID | K992065 |
| 510k Number | K992065 |
| Device Name: | GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Janet Johnson |
| Correspondent | Janet Johnson DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-18 |
| Decision Date | 1999-07-12 |
| Summary: | summary |