The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Bioraptor Suture Anchor, Twinfix 2.8 Mm Suture Anchor, Twinfix 3.5 Mm Suture Anchor.
| Device ID | K053344 |
| 510k Number | K053344 |
| Device Name: | BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MAI |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2006-02-23 |
| Summary: | summary |