The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Delta Humeral Cups.
Device ID | K050315 |
510k Number | K050315 |
Device Name: | DELTA HUMERAL CUPS |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Tiffani D Rogers |
Correspondent | Tiffani D Rogers DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-09 |
Decision Date | 2005-05-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295170525 | K050315 | 000 |
10603295170518 | K050315 | 000 |
10603295170464 | K050315 | 000 |
10603295170457 | K050315 | 000 |