The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for 2.0 Pk Suture Anchor T, 2.0 Pk Suture Anchor S.
| Device ID | K081511 |
| 510k Number | K081511 |
| Device Name: | 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MBI |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-29 |
| Decision Date | 2008-08-26 |
| Summary: | summary |