The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Delta Xtend Reverse Shoulder Modular Stem.
| Device ID | K071379 |
| 510k Number | K071379 |
| Device Name: | DELTA XTEND REVERSE SHOULDER MODULAR STEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-17 |
| Decision Date | 2007-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295027331 | K071379 | 000 |
| 10603295027171 | K071379 | 000 |
| 10603295027225 | K071379 | 000 |
| 10603295027270 | K071379 | 000 |
| 10603295027287 | K071379 | 000 |
| 10603295027294 | K071379 | 000 |
| 10603295027300 | K071379 | 000 |
| 10603295027317 | K071379 | 000 |
| 10603295027324 | K071379 | 000 |
| 10603295027126 | K071379 | 000 |