The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Fx Humeral Stem, Global Advantage Humeral Head.
| Device ID | K984541 |
| 510k Number | K984541 |
| Device Name: | GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Arlene C Saull |
| Correspondent | Arlene C Saull DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295005049 | K984541 | 000 |
| 10603295005018 | K984541 | 000 |
| 10603295004981 | K984541 | 000 |
| 10603295004950 | K984541 | 000 |