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 |