The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Delta Cta Reverse Shoulder System Humeral Heads.
| Device ID | K062116 |
| 510k Number | K062116 |
| Device Name: | DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-25 |
| Decision Date | 2006-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295265429 | K062116 | 000 |
| 10603295265412 | K062116 | 000 |
| 10603295265405 | K062116 | 000 |
| 10603295265399 | K062116 | 000 |