QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM— 510(k) K953264

Substantially Equivalent for Some Indications

Wrightmedicaltechnologyinc

FDA 510(k) clearance K953264 for QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM, Substantially Equivalent for Some Indications on 1995-10-20. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1995-07-13
Decision date: 1995-10-20
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Arlington, TN, 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.