OEC/REZAIAN SPINAL FIXATOR— 510(k) K841189

Name: FDA 510(k) clearance K841189
Creator: U.S. Food and Drug Administration
Published: 1984-05-16

Substantially Equivalent

Orthopedic Equipment Co., Inc.

FDA 510(k) clearance K841189 for OEC/REZAIAN SPINAL FIXATOR, Substantially Equivalent on 1984-05-16. Applicant: Orthopedic Equipment Co., Inc.. Device class: 2.

Clearance details

Applicant: Orthopedic Equipment Co., Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 1984-03-20
Decision date: 1984-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.