TRUE SPINAL FIXATION SYSTEM— 510(k) K130958

Name: FDA 510(k) clearance K130958
Creator: U.S. Food and Drug Administration
Published: 2013-10-17

Substantially Equivalent

Innovative Surgical Designs

FDA 510(k) clearance K130958 for TRUE SPINAL FIXATION SYSTEM, Substantially Equivalent on 2013-10-17. Applicant: Innovative Surgical Designs. Device class: 2.

Clearance details

Applicant: Innovative Surgical Designs
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2013-04-05
Decision date: 2013-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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K133690 — TRUE SPINAL FUSSION SYSTEM2014-05-07

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.