FDA applicant
Atlas Spine, Inc.
FDA records 19 decisions for Atlas Spine, Inc. (Jupiter, FL) from 2007 to 2026: 19 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and MQP (Spinal Vertebral Body Replacement Device). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 9 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Atlas Spine, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Atlas Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2013
Class I Class II/III not classified
Planning a device like Atlas Spine, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Atlas”
FDA records each applicant name separately; these may or may not be the same firm.