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

Name: FDA 510(k) clearance K953264
Creator: U.S. Food and Drug Administration
Published: 1995-10-20

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. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
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

Download summary PDF View on FDA.gov ↗

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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.