The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Twinfix Ultra Ti, Twinfix Ultra Pk, Twinfix Ultra Ha Suture Anchors.
| Device ID | K112526 |
| 510k Number | K112526 |
| Device Name: | TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Melissa Egan |
| Correspondent | Melissa Egan SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2012-01-31 |
| Summary: | summary |