STINGRAY CERVICAL CAGE— 510(k) K122085

Substantially Equivalent

Omni Surgical, LP Dba Spine360

FDA 510(k) clearance K122085 for STINGRAY CERVICAL CAGE, Substantially Equivalent on 2012-10-17. Applicant: Omni Surgical, LP Dba Spine360.

Clearance details

Applicant: Omni Surgical, LP Dba Spine360
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2012-07-16
Decision date: 2012-10-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Austin, TX, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.