The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Division with the FDA for Smith & Nephew Kinsa Rc Suture Anchor.
| Device ID | K070908 |
| 510k Number | K070908 |
| Device Name: | SMITH & NEPHEW KINSA RC SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell SMITH & NEPHEW INC., ENDOSCOPY DIVISION 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 | 2007-04-02 |
| Decision Date | 2007-05-16 |
| Summary: | summary |