NANO SUTURE ANCHOR— 510(k) K112965

Substantially Equivalent

Linvatec Corporation D/B/A Conmed Linvatec

FDA 510(k) clearance K112965 for NANO SUTURE ANCHOR, Substantially Equivalent on 2011-11-02. Applicant: Linvatec Corporation D/B/A Conmed Linvatec.

Clearance details

Applicant: Linvatec Corporation D/B/A Conmed Linvatec
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2011-10-05
Decision date: 2011-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Largo, FL, 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.