The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Advantage Humeral Stem With Porocoat.
Device ID | K011047 |
510k Number | K011047 |
Device Name: | GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
Contact | Marcia Arentz |
Correspondent | Marcia Arentz DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. 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 | 2001-04-06 |
Decision Date | 2001-06-28 |