OMNI Skirted Heads— 510(k) K152919

Substantially Equivalent

Omni Life Science, Inc.

FDA 510(k) clearance K152919 for OMNI Skirted Heads, Substantially Equivalent on 2016-03-10. Applicant: Omni Life Science, Inc..

Clearance details

Applicant: Omni Life Science, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2015-10-02
Decision date: 2016-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Taunton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.