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)

SYNFIX -LR

K-Number: K062083 · 2007-04-03

ApplicantSynthes Spine Co.Lp
Decision Date2007-04-03
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNFIX -LR is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine Co.Lp. It received FDA 510(k) clearance on 2007-04-03 under 510(k) number K062083. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNFIX -LR?

SYNFIX -LR is a medical device that received FDA 510(k) clearance on 2007-04-03. The listed applicant is Synthes Spine Co.Lp. The 510(k) number is K062083.

When did SYNFIX -LR receive FDA 510(k) clearance?

SYNFIX -LR received FDA 510(k) clearance on 2007-04-03, under 510(k) number K062083.

Who is the listed applicant for SYNFIX -LR?

The FDA 510(k) record lists Synthes Spine Co.Lp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNFIX -LR?

The FDA product code for SYNFIX -LR is MQP.

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 Synthes Spine Co.Lp 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.

K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)K112459SYNTHES ZERO-PK112068SYNTHES ZERO-P VARIABLE ANGLE (VA)K103320SYNTHES XRLK081568ANTEGRA-TK080020ARCOFIX

View all 18 devices →

Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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.

↑