CENTRE-DRIVE DRILL-FREE SCREW— 510(k) K971297

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K971297 for CENTRE-DRIVE DRILL-FREE SCREW, Substantially Equivalent on 1997-05-08. Applicant: KLS-Martin L.P..

Clearance details

Applicant: KLS-Martin L.P.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1997-04-08
Decision date: 1997-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.