ABC-1000 SMALL JOINT REAMERS— 510(k) K862933

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K862933 for ABC-1000 SMALL JOINT REAMERS, Substantially Equivalent on 1986-08-18. Applicant: Instrumentation Industries, Inc..

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code HTO
Advisory panel: Orthopedic
Date received: 1986-08-04
Decision date: 1986-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

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Adverse events under product code HTO

product code HTO

Injury: 404
Malfunction: 20,305
Total: 20,709

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.