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FDA 510(k)

PEEK TETRIS SPINAL IMPLANT

K-Number: K031757 · 2003-07-30

ApplicantSignus Medical, LLC
Decision Date2003-07-30
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK TETRIS SPINAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medical, LLC. It received FDA 510(k) clearance on 2003-07-30 under 510(k) number K031757. 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 PEEK TETRIS SPINAL IMPLANT?

PEEK TETRIS SPINAL IMPLANT is a medical device that received FDA 510(k) clearance on 2003-07-30. The listed applicant is Signus Medical, LLC. The 510(k) number is K031757.

When did PEEK TETRIS SPINAL IMPLANT receive FDA 510(k) clearance?

PEEK TETRIS SPINAL IMPLANT received FDA 510(k) clearance on 2003-07-30, under 510(k) number K031757.

Who is the listed applicant for PEEK TETRIS SPINAL IMPLANT?

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

What is the FDA product code for PEEK TETRIS SPINAL IMPLANT?

The FDA product code for PEEK TETRIS SPINAL IMPLANT 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 Signus Medical, 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.

K081108MONOPOLY PEDICLE SCREW SYSTEMK052096NUBIC SPINAL IMPLANTK031455CONKLUSION PEDICLE SCREW SYSTEMK022793TETRIS SPINAL IMPLANTK020836RABEA CEMENT RESTRICTOR

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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