Cleared Traditional

Atlas Spine Rebar (Ti) Spacer System

K202302 · Atlas Spine, Inc. · Orthopedic

Oct 2020

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K202302 is an FDA 510(k) clearance for the Atlas Spine Rebar (Ti) Spacer System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on October 30, 2020, 77 days after receiving the submission on August 14, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K202302 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2020
Decision Date	October 30, 2020
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.