Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRUE SPINAL FIXATION SYSTEM

K-Number: K130958 · 2013-10-17

ApplicantInnovative Surgical Designs
Decision Date2013-10-17
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUE SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Designs. It received FDA 510(k) clearance on 2013-10-17 under 510(k) number K130958. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE SPINAL FIXATION SYSTEM?

TRUE SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-17. The listed applicant is Innovative Surgical Designs. The 510(k) number is K130958.

When did TRUE SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

TRUE SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2013-10-17, under 510(k) number K130958.

Who is the listed applicant for TRUE SPINAL FIXATION SYSTEM?

The FDA 510(k) record lists Innovative Surgical Designs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUE SPINAL FIXATION SYSTEM?

The FDA product code for TRUE SPINAL FIXATION SYSTEM is MNI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: MNI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑