QUANTUM SPINAL SYSTEM, QUANTUM MIS— 510(k) K101790

Substantially Equivalent

Pioneer Surgical Technology

FDA 510(k) clearance K101790 for QUANTUM SPINAL SYSTEM, QUANTUM MIS, Substantially Equivalent on 2011-03-07. Applicant: Pioneer Surgical Technology.

Clearance details

Applicant: Pioneer Surgical Technology
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2010-06-28
Decision date: 2011-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Newbury, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.