ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium— 510(k) K172199

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K172199 for ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, Substantially Equivalent on 2017-09-19. Applicant: Medtronic Sofamor Danek.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2017-07-21
Decision date: 2017-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.