SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25— 510(k) K092659

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K092659 for SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25, Substantially Equivalent on 2009-11-17. Applicant: Spinal USA.

Clearance details

Applicant: Spinal USA
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2009-08-28
Decision date: 2009-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pear, MS, 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.