BIOSURE REGENESORB interference Screw— 510(k) K142948

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K142948 for BIOSURE REGENESORB interference Screw, Substantially Equivalent on 2015-01-13. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2014-10-10
Decision date: 2015-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.