# Spineology, Inc.

- Location (FDA's records): Saint Paul, MN
- FDA decisions: 54 (1999–2025): 53 510(k) clearances and 1 De Novo grant
- Product codes: MAX (22), NKB (12), OLO (5), OVD (4), OQB (4), KWQ (2), PEK (1), MRW (1), KWP (1), EZX (1), JDK (1)
- 510(k) review time since 2016: median 77 days, against 97 for FDA's reviews in the same codes and years (19 of 29 faster)
- Predicates its devices cite: 132 (85 its own); citations of its devices by later devices: 98 (85 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes Spine: 6 (https://510kreport.com/company/synthes-spine)
- Alphatec Spine, Inc.: 5 (https://510kreport.com/company/alphatec-spine)
- Aesculap Implant Systems, LLC: 4 (https://510kreport.com/company/aesculap-implant-systems)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Innova Spinal Technologies, LLC: 2 (https://510kreport.com/company/innova-spinal-technologies)
- Lanx, Inc.: 2 (https://510kreport.com/company/lanx)

## Firms that cite its devices most
- Aesculap, Inc.: 4 (https://510kreport.com/company/aesculap)
- Trans1 Incorporated: 1 (https://510kreport.com/company/trans1)
- Anova Corporation: 1 (https://510kreport.com/company/anova)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)
- Regen Biologics, Inc.: 1 (https://510kreport.com/company/regen-biologics)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Nuvasive, Inc.: 1 (https://510kreport.com/company/nuvasive)

## Its most-cited devices
- K111880: Spineolgy Peek Bullet Lumber Interbody Fusion Device (2011), cited by 7
- K113030: Spineology Peek Bullet Lumbar Interbody Fusion Device (2012), cited by 6
- K140010: Fortress Pedicle Screw System (2014), cited by 5
- K143403: Threshold Pedicular Fixation System (2014), cited by 5
- K120293: Spineology Peek Lumbar Interbody Fusion Drive (2012), cited by 5
- K132053: Rampart-O, Rampart-T (2013), cited by 5

## Recent decisions
- K251302: OptiMesh Multiplanar Expandable Interbody Fusion System (Dec 15, 2025)
- K251943: Spineology Navigation Instruments (Dec 4, 2025)
- K230927: OptiMesh Multiplanar Expandable Interbody Fusion System (Nov 1, 2023)
- K231781: OptiMesh Multiplanar Expandable Interbody Fusion System (Oct 18, 2023)
- K213876: Spineology Navigation Instruments (Aug 5, 2022)
- K210155: Duo Expandable Interbody Fusion System (Feb 19, 2021)
- DEN200010: Spineology Interbody Fusion System (Sep 18, 2020)
- K192047: Rampart™ One Lumbar Interbody Fusion System (Aug 23, 2019)

Source page: https://510kreport.com/company/spineology