TORNIER INSITE FT SUTURE ANCHOR— 510(k) K110773

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K110773 for TORNIER INSITE FT SUTURE ANCHOR, Substantially Equivalent on 2011-06-02. Applicant: Tornier, Inc..

Clearance details

Applicant: Tornier, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2011-03-21
Decision date: 2011-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

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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.