TRUE SPINAL FUSSION SYSTEM— 510(k) K133690

Substantially Equivalent

Innovative Surgical Designs

FDA 510(k) clearance K133690 for TRUE SPINAL FUSSION SYSTEM, Substantially Equivalent on 2014-05-07. Applicant: Innovative Surgical Designs.

Clearance details

Applicant: Innovative Surgical Designs
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2013-12-02
Decision date: 2014-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.