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FDA 510(k)

ATLAS SPINE SPACER

K-Number: K081880 · 2008-10-02

ApplicantAtlas Spine, Inc.
Decision Date2008-10-02
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATLAS SPINE SPACER 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 2008-10-02 under 510(k) number K081880. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLAS SPINE SPACER?

ATLAS SPINE SPACER is a medical device that received FDA 510(k) clearance on 2008-10-02. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K081880.

When did ATLAS SPINE SPACER receive FDA 510(k) clearance?

ATLAS SPINE SPACER received FDA 510(k) clearance on 2008-10-02, under 510(k) number K081880.

Who is the listed applicant for ATLAS SPINE SPACER?

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 SPACER?

The FDA product code for ATLAS SPINE SPACER is ODP.

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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: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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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