HARRINGTON SPINE INSTRUMENTATION— 510(k) K781443

Substantially Equivalent

Orthopedic Equipment Co., Inc.

FDA 510(k) clearance K781443 for HARRINGTON SPINE INSTRUMENTATION, Substantially Equivalent on 1978-09-27. Applicant: Orthopedic Equipment Co., Inc..

Clearance details

Applicant: Orthopedic Equipment Co., Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1978-08-23
Decision date: 1978-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.