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FDA 510(k)

DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS

K-Number: K053292 · 2006-01-19

ApplicantScient'X USA, Inc.
Decision Date2006-01-19
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X USA, Inc.. It received FDA 510(k) clearance on 2006-01-19 under 510(k) number K053292. 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 DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS?

DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS is a medical device that received FDA 510(k) clearance on 2006-01-19. The listed applicant is Scient'X USA, Inc.. The 510(k) number is K053292.

When did DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS receive FDA 510(k) clearance?

DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS received FDA 510(k) clearance on 2006-01-19, under 510(k) number K053292.

Who is the listed applicant for DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS?

The FDA 510(k) record lists Scient'X USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS?

The FDA product code for DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS 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 Scient'X USA, Inc. 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.

K081548ANTERIOR BUTTRESS PLATEK080588SCIENT'X TRIBECA VBRK031290MODIFICATION TO EASYS TRANSVERSE CONNECTION

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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