Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Atlas Spine, Inc. · Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
163 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.2026-07-153140
K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.2025-11-10890
K251969Atlas Spine Project X Expandable Posterior Lumbar Interbody Atlas Spine, Inc.2025-08-15500
K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc.2024-11-26570
K202302Atlas Spine Rebar (Ti) Spacer SystemAtlas Spine, Inc.2020-10-30770
K192570Atlas Spine Expandable Cervical Standalone Interbody SystemAtlas Spine, Inc.2020-02-281630
K182418V3 Segmental Plating SystemAtlas Spine, Inc.2018-11-29850
K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.2018-06-13900
K172334Ortus™ Expandable Lumbar Interbody Fusion SystemAtlas Spine, Inc.2017-10-25840
K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.2017-02-091140
K112759APCLO PEDICLE SCREW SYSTEMSAtlas Spine, Inc.2011-10-18260
K110842ATLAS SPINE PEDICLE SCREW SYSTEMAtlas Spine, Inc.2011-07-131100
K100743ATLAS SPINE PIVOTING SYSTEMAtlas Spine, Inc.2010-08-101470
K081880ATLAS SPINE SPACERAtlas Spine, Inc.2008-10-02920
K071497ATLAS SPINE VERTEBRAL BODY REPLACEMENTAtlas Spine, Inc.2007-06-29290
K063464ATLAS SPINE VERTEBRAL BODY REPLACEMENTAtlas Spine, Inc.2007-03-091130

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda