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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 a medical device manufactured by Atlas Spine, Inc.. It received FDA 510(k) clearance on 2020-10-30 under approval 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. It is manufactured by Atlas Spine, Inc.. The 510(k) number is K202302.

When was Atlas Spine Rebar (Ti) Spacer System approved by the FDA?

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

What company makes Atlas Spine Rebar (Ti) Spacer System?

Atlas Spine Rebar (Ti) Spacer System is manufactured by Atlas Spine, Inc..

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.

Related Clinical Trials

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Other Devices by Atlas Spine, Inc.

K172334Ortus™ Expandable Lumbar Interbody Fusion System K162918Atlas Spine Expandable Interbody System K182418V3 Segmental Plating System K180675Atlas Spine Expandable Cervical Interbody System K192570Atlas Spine Expandable Cervical Standalone Interbody System K243191Atlas Spine Lateral Expandable Interbody System

View all 9 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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