The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Ap Porous Coated Humeral Stem.
| Device ID | K063652 |
| 510k Number | K063652 |
| Device Name: | GLOBAL AP POROUS COATED HUMERAL STEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Rebecca Lennard |
| Correspondent | Rebecca Lennard DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | MBF |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-08 |
| Decision Date | 2007-02-01 |
| Summary: | summary |