The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Aequalis Adjustable Reverse Shoulder System.
| Device ID | K141029 |
| 510k Number | K141029 |
| Device Name: | TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Contact | Kristine Tucker |
| Correspondent | Kristine Tucker TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-22 |
| Decision Date | 2014-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832068401 | K141029 | 000 |
| 00846832011360 | K141029 | 000 |
| 00846832011353 | K141029 | 000 |
| 00846832011346 | K141029 | 000 |
| 00846832011339 | K141029 | 000 |
| 00846832011322 | K141029 | 000 |
| 00846832011315 | K141029 | 000 |
| 00846832011308 | K141029 | 000 |
| 00846832011292 | K141029 | 000 |
| 00846832011377 | K141029 | 000 |
| 00846832068319 | K141029 | 000 |
| 00846832068395 | K141029 | 000 |
| 00846832068388 | K141029 | 000 |
| 00846832068371 | K141029 | 000 |
| 00846832068364 | K141029 | 000 |
| 00846832068357 | K141029 | 000 |
| 00846832068340 | K141029 | 000 |
| 00846832068333 | K141029 | 000 |
| 00846832068326 | K141029 | 000 |
| 00846832011285 | K141029 | 000 |