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 |