The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Global Shoulder Glenoid.
Device ID | K981487 |
510k Number | K981487 |
Device Name: | DEPUY GLOBAL SHOULDER GLENOID |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Sally Foust |
Correspondent | Sally Foust 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 | 1998-04-27 |
Decision Date | 1998-07-13 |
Summary: | summary |