BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM— 510(k) K093943

Substantially Equivalent

Smith & Nephew Inc., Endoscopy Div.

FDA 510(k) clearance K093943 for BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM, Substantially Equivalent on 2010-03-05. Applicant: Smith & Nephew Inc., Endoscopy Div..

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Div.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2009-12-22
Decision date: 2010-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.