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)

LEFORTE NEURO SYSTEM BONE PLATE

K-Number: K112812 · 2012-02-22

ApplicantJeil Medical Corporation
Decision Date2012-02-22
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LEFORTE NEURO SYSTEM BONE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2012-02-22 under 510(k) number K112812. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEFORTE NEURO SYSTEM BONE PLATE?

LEFORTE NEURO SYSTEM BONE PLATE is a medical device that received FDA 510(k) clearance on 2012-02-22. The listed applicant is Jeil Medical Corporation. The 510(k) number is K112812.

When did LEFORTE NEURO SYSTEM BONE PLATE receive FDA 510(k) clearance?

LEFORTE NEURO SYSTEM BONE PLATE received FDA 510(k) clearance on 2012-02-22, under 510(k) number K112812.

Who is the listed applicant for LEFORTE NEURO SYSTEM BONE PLATE?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEFORTE NEURO SYSTEM BONE PLATE?

The FDA product code for LEFORTE NEURO SYSTEM BONE PLATE is GWO.

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

Other records listing Jeil Medical Corporation as applicant

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.

K252246Leforte MMF SystemK252826ARIX Femur Nail SystemK251431FIX-C PEEK ACIF SA SystemK243973FIX-L PEEK PLIF and T-PLIF SystemK242751ARIX Pectus Bar SystemK242247ARIX Femur Nail System

View all 48 devices →

Related Devices (Code: GWO)

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.

K262874CraniUS PlateCraniUS, LLCK261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.

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.

↑