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

Name: FDA 510(k) clearance K934044
Creator: U.S. Food and Drug Administration
Published: 1994-03-10

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.. Device class: 2.

Clearance details

Applicant: Smith and Nephew Donjoy, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1993-08-19
Decision date: 1994-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carsbad, CA, US

Download summary PDF View on FDA.gov ↗

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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.