MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K080690

Substantially Equivalent

Theken Spine, LLC

FDA 510(k) clearance K080690 for MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2008-04-25. Applicant: Theken Spine, LLC.

Clearance details

Applicant: Theken Spine, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2008-03-11
Decision date: 2008-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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.