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Atlas Spine, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
18
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1616-2016Class IIAtlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into July 26, 2013
Z-2274-2012Class IIApelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***AtlasJune 4, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemNovember 10, 2025
K251969Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemAugust 15, 2025
K243191Atlas Spine Lateral Expandable Interbody SystemNovember 26, 2024
K202302Atlas Spine Rebar (Ti) Spacer SystemOctober 30, 2020
K192570Atlas Spine Expandable Cervical Standalone Interbody SystemFebruary 28, 2020
K182418V3 Segmental Plating SystemNovember 29, 2018
K180675Atlas Spine Expandable Cervical Interbody SystemJune 13, 2018
K172334Ortus™ Expandable Lumbar Interbody Fusion SystemOctober 25, 2017
K162918Atlas Spine Expandable Interbody SystemFebruary 9, 2017
K112759APCLO PEDICLE SCREW SYSTEMSOctober 18, 2011
K110842ATLAS SPINE PEDICLE SCREW SYSTEMJuly 13, 2011
K100743ATLAS SPINE PIVOTING SYSTEMAugust 10, 2010
K091406ATLAS SPINE SPACERSeptember 4, 2009
K081880ATLAS SPINE SPACEROctober 2, 2008
K072426ATLAS SPINE PEDICLE SCREW SYSTEMOctober 19, 2007
K071497ATLAS SPINE VERTEBRAL BODY REPLACEMENTJune 29, 2007
K063464ATLAS SPINE VERTEBRAL BODY REPLACEMENTMarch 9, 2007
K063205ATLAS SPINE VERTEBRAL BODY REPLACEMENTFebruary 26, 2007