ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM— 510(k) K934044

Substantially Equivalent

Smith and Nephew Donjoy, Inc.

FDA 510(k) clearance K934044 for ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM, Substantially Equivalent on 1994-03-10. Applicant: Smith and Nephew Donjoy, Inc..

Clearance details

Applicant: Smith and Nephew Donjoy, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1993-08-19
Decision date: 1994-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carsbad, CA, US

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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.