REFLEX HYBRID ACP SYSTEM— 510(k) K062310

Substantially Equivalent

Stryker Spine

FDA 510(k) clearance K062310 for REFLEX HYBRID ACP SYSTEM, Substantially Equivalent on 2006-08-18. Applicant: Stryker Spine.

Clearance details

Applicant: Stryker Spine
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2006-08-08
Decision date: 2006-08-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, 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.