# Atlas Spine, Inc.

- Location (FDA's records): Jupiter, FL
- FDA decisions: 19 (2007–2026): 19 510(k) clearances
- Names in FDA's records: Atlas Spine, Inc. (16); Atlas Spine, LLC (3)
- Product codes: MAX (4), MQP (4), NKB (3), ODP (3), PLR (2), OVE (1), KWQ (1), OVD (1)
- 510(k) review time since 2016: median 85 days, against 113 for FDA's reviews in the same codes and years (7 of 8 faster)
- Predicates its devices cite: 35 (9 its own); citations of its devices by later devices: 21 (9 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Quantum Orthopedics, Inc.: 4 (https://510kreport.com/company/quantum-orthopedics)
- Stryker Spine: 3 (https://510kreport.com/company/stryker-spine)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Pioneer Surgical Technology: 2 (https://510kreport.com/company/pioneer-surgical-technology)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)
- Depuyacromed: 1 (https://510kreport.com/company/depuyacromed)
- Howmedica Corp.: 1 (https://510kreport.com/company/howmedica)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)

## Firms that cite its devices most
- Spine Wave, Inc.: 1 (https://510kreport.com/company/spine-wave)
- Ht Medical D.B.A. Xenix Medical: 1 (https://510kreport.com/company/ht-medical-dba-xenix-medical)
- Spineart: 1 (https://510kreport.com/company/spineart)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Omnia Medical, LLC: 1 (https://510kreport.com/company/omnia-medical)
- Evolution Spine: 1 (https://510kreport.com/company/evolution-spine)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- U&I Corporation: 1 (https://510kreport.com/company/u-i)

## Its most-cited devices
- K192570: Atlas Spine Expandable Cervical Standalone Interbody System (2020), cited by 4
- K072426: Atlas Spine Pedicle Screw System (2007), cited by 2
- K110842: Atlas Spine Pedicle Screw System (2011), cited by 2
- K162918: Atlas Spine Expandable Interbody System (2017), cited by 2
- K063464: Atlas Spine Vertebral Body Replacement (2007), cited by 2
- K182418: V3 Segmental Plating System (2018), cited by 2

## Recent decisions
- K252822: Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (Jul 15, 2026)
- K252560: Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (Nov 10, 2025)
- K251969: Atlas Spine Project X Expandable Posterior Lumbar Interbody System (Aug 15, 2025)
- K243191: Atlas Spine Lateral Expandable Interbody System (Nov 26, 2024)
- K202302: Atlas Spine Rebar (Ti) Spacer System (Oct 30, 2020)
- K192570: Atlas Spine Expandable Cervical Standalone Interbody System (Feb 28, 2020)
- K182418: V3 Segmental Plating System (Nov 29, 2018)
- K180675: Atlas Spine Expandable Cervical Interbody System (Jun 13, 2018)

Source page: https://510kreport.com/company/atlas-spine