PARAMOUNT VBR SYSTEM— 510(k) K062759

Substantially Equivalent

Innovative Spinal Technologies, Inc.

FDA 510(k) clearance K062759 for PARAMOUNT VBR SYSTEM, Substantially Equivalent on 2007-01-12. Applicant: Innovative Spinal Technologies, Inc..

Clearance details

Applicant: Innovative Spinal Technologies, Inc.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2006-09-15
Decision date: 2007-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.