The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for All-suture Anchor Twist Drill For All-suture Anchors Inline Drill Guide For All-suture Anchors.
| Device ID | K122059 |
| 510k Number | K122059 |
| Device Name: | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Karin Desjardins |
| Correspondent | Karin Desjardins 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 | 2012-07-13 |
| Decision Date | 2013-03-18 |
| Summary: | summary |