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 |