510(k) K121482— INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY

Substantially Equivalent

Theken Spine, LLC

Clearance details

Applicant: Theken Spine, LLC
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2012-05-18
Decision date: 2012-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medina, OH, US

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.