RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM— 510(k) K130105

Substantially Equivalent

Depuy Mitek, A Johnson & Johnson Company

FDA 510(k) clearance K130105 for RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM, Substantially Equivalent on 2013-05-17. Applicant: Depuy Mitek, A Johnson & Johnson Company.

Clearance details

Applicant: Depuy Mitek, A Johnson & Johnson Company
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2013-01-15
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.