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FDA 510(k)

ATLAS SPINE VERTEBRAL BODY REPLACEMENT

K-Number: K071497 · 2007-06-29

ApplicantAtlas Spine, Inc.
Decision Date2007-06-29
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATLAS SPINE VERTEBRAL BODY REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K071497. 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 ATLAS SPINE VERTEBRAL BODY REPLACEMENT?

ATLAS SPINE VERTEBRAL BODY REPLACEMENT is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K071497.

When did ATLAS SPINE VERTEBRAL BODY REPLACEMENT receive FDA 510(k) clearance?

ATLAS SPINE VERTEBRAL BODY REPLACEMENT received FDA 510(k) clearance on 2007-06-29, under 510(k) number K071497.

Who is the listed applicant for ATLAS SPINE VERTEBRAL BODY REPLACEMENT?

The FDA 510(k) record lists Atlas Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATLAS SPINE VERTEBRAL BODY REPLACEMENT?

The FDA product code for ATLAS SPINE VERTEBRAL BODY REPLACEMENT is MQP.

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Other records listing Atlas Spine, 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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantK252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemK251969Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemK243191Atlas Spine Lateral Expandable Interbody SystemK202302Atlas Spine Rebar (Ti) Spacer SystemK192570Atlas Spine Expandable Cervical Standalone Interbody System

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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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