CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX— 510(k) K100061

Name: FDA 510(k) clearance K100061
Creator: U.S. Food and Drug Administration
Published: 2010-02-12

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K100061 for CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX, Substantially Equivalent on 2010-02-12. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2010-01-11
Decision date: 2010-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.