The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Div. with the FDA for Biosure Sync Tibial Fixation Device, 6mm, 8mm,10mm,12mm.
| Device ID | K093943 |
| 510k Number | K093943 |
| Device Name: | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Julie Acker |
| Correspondent | Julie Acker SMITH & NEPHEW INC., ENDOSCOPY DIV. 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 | 2009-12-22 |
| Decision Date | 2010-03-05 |
| Summary: | summary |