The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Delta Xtend Reverse Shoulder System.
Device ID | K062250 |
510k Number | K062250 |
Device Name: | DELTA XTEND REVERSE SHOULDER SYSTEM |
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 | 2006-08-02 |
Decision Date | 2007-02-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295027102 | K062250 | 000 |
10603295027256 | K062250 | 000 |
10603295027263 | K062250 | 000 |
10603295027348 | K062250 | 000 |
10603295027355 | K062250 | 000 |
10603295027362 | K062250 | 000 |
10603295027379 | K062250 | 000 |
10603295027386 | K062250 | 000 |
10603295027522 | K062250 | 000 |
10603295027249 | K062250 | 000 |
10603295027232 | K062250 | 000 |
10603295027218 | K062250 | 000 |
10603295027119 | K062250 | 000 |
10603295027133 | K062250 | 000 |
10603295027140 | K062250 | 000 |
10603295027157 | K062250 | 000 |
10603295027164 | K062250 | 000 |
10603295027188 | K062250 | 000 |
10603295027195 | K062250 | 000 |
10603295027201 | K062250 | 000 |
10603295027539 | K062250 | 000 |
10603295027546 | K062250 | 000 |
10603295027805 | K062250 | 000 |
10603295027812 | K062250 | 000 |
10603295027829 | K062250 | 000 |
10603295027836 | K062250 | 000 |
10603295027843 | K062250 | 000 |
10603295027850 | K062250 | 000 |
10603295027867 | K062250 | 000 |
10603295027874 | K062250 | 000 |
10603295027799 | K062250 | 000 |
10603295027782 | K062250 | 000 |
10603295027775 | K062250 | 000 |
10603295027553 | K062250 | 000 |
10603295027690 | K062250 | 000 |
10603295027706 | K062250 | 000 |
10603295027713 | K062250 | 000 |
10603295027720 | K062250 | 000 |
10603295027744 | K062250 | 000 |
10603295027751 | K062250 | 000 |
10603295027768 | K062250 | 000 |
10603295027737 | K062250 | 000 |