CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116— 510(k) K012334

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K012334 for CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116, Substantially Equivalent on 2001-09-19. Applicant: Bionx Implants, Inc..

Clearance details

Applicant: Bionx Implants, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2001-07-24
Decision date: 2001-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.