SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115— 510(k) K093820

Substantially Equivalent

Memometal Technologies

FDA 510(k) clearance K093820 for SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115, Substantially Equivalent on 2010-05-19. Applicant: Memometal Technologies.

Clearance details

Applicant: Memometal Technologies
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2009-12-14
Decision date: 2010-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bruz, FR

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.