Atlas Spine Rebar (Ti) Spacer System

Intervertebral Fusion Device With Bone Graft, Cervical

Atlas Spine, Inc.

The following data is part of a premarket notification filed by Atlas Spine, Inc. with the FDA for Atlas Spine Rebar (ti) Spacer System.

Pre-market Notification Details

Device IDK202302
510k NumberK202302
Device Name:Atlas Spine Rebar (Ti) Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter,  FL  33458
ContactThomas Smith
CorrespondentThomas Smith
Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter,  FL  33458
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-14
Decision Date2020-10-30

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