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FDA 510(k)

Atlas Spine Rebar (Ti) Spacer System

K-Number: K202302 · 2020-10-30

ApplicantAtlas Spine, Inc.
Decision Date2020-10-30
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Atlas Spine Rebar (Ti) Spacer System 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 2020-10-30 under 510(k) number K202302. 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 Rebar (Ti) Spacer System?

Atlas Spine Rebar (Ti) Spacer System is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K202302.

When did Atlas Spine Rebar (Ti) Spacer System receive FDA 510(k) clearance?

Atlas Spine Rebar (Ti) Spacer System received FDA 510(k) clearance on 2020-10-30, under 510(k) number K202302.

Who is the listed applicant for Atlas Spine Rebar (Ti) Spacer System?

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 Rebar (Ti) Spacer System?

The FDA product code for Atlas Spine Rebar (Ti) Spacer System is ODP.

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 SystemK192570Atlas Spine Expandable Cervical Standalone Interbody SystemK182418V3 Segmental Plating 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.

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.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

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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