The following data is part of a premarket notification filed by Depuy France with the FDA for Depuy Cta Reverse Shoulder System.
Device ID | K122442 |
510k Number | K122442 |
Device Name: | DEPUY CTA REVERSE SHOULDER SYSTEM |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | DEPUY FRANCE 700 ORTHOPAEDIC DRIVE Warsaw, IN 46580 |
Contact | Megan Burns |
Correspondent | Megan Burns DEPUY FRANCE 700 ORTHOPAEDIC DRIVE Warsaw, IN 46580 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-10 |
Decision Date | 2012-09-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295423720 | K122442 | 000 |
10603295423713 | K122442 | 000 |
10603295423706 | K122442 | 000 |
10603295423690 | K122442 | 000 |
10603295423683 | K122442 | 000 |
10603295423676 | K122442 | 000 |
10603295423669 | K122442 | 000 |