VERSALOK SCREW ASSEMBLY (PROPOSED NAME)— 510(k) K961572

Substantially Equivalent for Some Indications

Wrightmedicaltechnologyinc

FDA 510(k) clearance K961572 for VERSALOK SCREW ASSEMBLY (PROPOSED NAME), Substantially Equivalent for Some Indications on 1996-09-17. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1996-04-23
Decision date: 1996-09-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Arlington, TN, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.