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FDA 510(k)

GSO GS1 SPACER

K-Number: K071274 · 2007-08-24

ApplicantGold Standard Orthopedics, LLC
Decision Date2007-08-24
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GSO GS1 SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Gold Standard Orthopedics, LLC. It received FDA 510(k) clearance on 2007-08-24 under 510(k) number K071274. 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 GSO GS1 SPACER?

GSO GS1 SPACER is a medical device that received FDA 510(k) clearance on 2007-08-24. The listed applicant is Gold Standard Orthopedics, LLC. The 510(k) number is K071274.

When did GSO GS1 SPACER receive FDA 510(k) clearance?

GSO GS1 SPACER received FDA 510(k) clearance on 2007-08-24, under 510(k) number K071274.

Who is the listed applicant for GSO GS1 SPACER?

The FDA 510(k) record lists Gold Standard Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSO GS1 SPACER?

The FDA product code for GSO GS1 SPACER 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 Gold Standard Orthopedics, LLC 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.

K110990GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM

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

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

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