The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Reversed Shoulder Prosthesis.
| Device ID | K030941 |
| 510k Number | K030941 |
| Device Name: | AEQUALIS REVERSED SHOULDER PROSTHESIS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | TORNIER 7651 S. 700 WEST SUITE 105 Salt Lake City, UT 84047 -7101 |
| Contact | Donald F Grabarz |
| Correspondent | Donald F Grabarz TORNIER 7651 S. 700 WEST SUITE 105 Salt Lake City, UT 84047 -7101 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-25 |
| Decision Date | 2004-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700386917158 | K030941 | 000 |