The following data is part of a premarket notification filed by Djo Surgical with the FDA for Reverse Shoulder Prosthesis.
Device ID | K092873 |
510k Number | K092873 |
Device Name: | REVERSE SHOULDER PROSTHESIS |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | DJO SURGICAL 9800 METRIC BOULEVARD Austin, TX 78758 |
Contact | Teffany Hutto |
Correspondent | Teffany Hutto DJO SURGICAL 9800 METRIC BOULEVARD Austin, TX 78758 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-18 |
Decision Date | 2009-10-27 |
Summary: | summary |