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FDA 510(k)

SYNEX II

K-Number: K061891 · 2006-08-18

ApplicantSynthes Spine Co.Lp
Decision Date2006-08-18
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNEX II 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 2006-08-18 under 510(k) number K061891. 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 SYNEX II?

SYNEX II is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is Synthes Spine Co.Lp. The 510(k) number is K061891.

When did SYNEX II receive FDA 510(k) clearance?

SYNEX II received FDA 510(k) clearance on 2006-08-18, under 510(k) number K061891.

Who is the listed applicant for SYNEX II?

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 SYNEX II?

The FDA product code for SYNEX II 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.

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