OSTEO ACL SCREW MODEL +1 more— 510(k) K032894

Name: FDA 510(k) clearance K032894
Creator: U.S. Food and Drug Administration
Published: 2004-05-07

Substantially Equivalent

Linvatec Biomaterials, Inc.

FDA 510(k) clearance K032894 for OSTEO ACL SCREW MODEL +1 more, Substantially Equivalent on 2004-05-07. Applicant: Linvatec Biomaterials, Inc.. Device class: 2.

Clearance details

Device name as filed: OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,
Applicant: Linvatec Biomaterials, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2003-09-17
Decision date: 2004-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

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.