The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Aequalis Humeral Nail; Sizes 7mm & 8mm X 210, 230, 250, 270mm; Left And Right.
| Device ID | K133376 |
| 510k Number | K133376 |
| Device Name: | AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Contact | Janell A Colley |
| Correspondent | Janell A Colley TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-04 |
| Decision Date | 2013-12-05 |
| Summary: | summary |