OMI OCCIPITAL CERVICAL LOOP, MODEL A1089— 510(k) K983282

Substantially Equivalent

Ohio Medical Instrument Co., Inc.

FDA 510(k) clearance K983282 for OMI OCCIPITAL CERVICAL LOOP, MODEL A1089, Substantially Equivalent on 1998-11-19. Applicant: Ohio Medical Instrument Co., Inc..

Clearance details

Applicant: Ohio Medical Instrument Co., Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1998-09-18
Decision date: 1998-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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.