FDA.reportPublic FDA data

SPINEOLOGY INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21351563003179719SPINEOLOGY INC.1N2026-01-017800 THIRD STREET N. SUITE 600 Saint Paul MN US 55128

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M7401001350Rampart One Lumbar Interbody Fusion System - Bayonetted Awl651-256-8500info@spineology.com
M7401001360Elite Expandable Interbody Fusion System - CEI 595 Shaver, 6mm651-256-8500info@spineology.com
M7401001361Elite Expandable Interbody Fusion System - CEI 595 Shaver, 7mm651-256-8500info@spineology.com
M7401001362Elite Expandable Interbody Fusion System - CEI 595 Shaver, 8mm651-256-8500info@spineology.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
560141393516606K251943Spineology Navigation InstrumentsOLO2025-12-04
560141765287586K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB2025-12-15
560141887141065K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB2023-10-18
560141587224265K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB2023-11-01
560141928586409K210155Duo Expandable Interbody Fusion SystemMAX2021-02-19
560141065217853K192047Rampart™ One Lumbar Interbody Fusion SystemOVD2019-08-23
560141848794374K191091Rampart One Lumbar Interbody Fusion SystemOVD2019-05-23
560141268604038K190055Duo Lumbar Interbody Fusion DeviceMAX2019-03-07
560141532587012K182345Spineology Navigation InstrumentsOLO2018-09-21
560141944658385K182322Duo Lumbar Interbody Fusion DeviceMAX2018-10-24
560141345620273K181792Duo™ Lumbar Interbody Fusion DeviceMAX2018-08-14
560141157188203K180796Spineology Navigation InstrumentsOLO2018-05-02
560141130488035K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation SystemNKB2017-08-21
560142051707664K171438Palisade™ Pedicular Fixation SystemNKB2017-06-02
560142034128727K170268Fortress™ Pedicular Fixation SystemNKB2017-04-14
560141348762302K170266Palisade™ Pedicular Fixation SystemNKB2017-04-14
560141069189232K170255Threshold™ V2 Pedicular Fixation SystemNKB2017-04-14
560141892944310K170251Threshold™ Pedicular Fixation SystemNKB2017-04-14
560141658401035K163670Rampart One Lumbar Interbody Fusion DeviceOVD2017-05-08
560141093686558K163409Rampart(TM) T Lumbar Interbody Fusion DeviceMAX2017-03-08
560141963764874K162879Elite Expandable Interbody Fusion DeviceMAX2017-01-30
560141827276702K161694Threshold™ Pedicular Fixation SystemNKB2016-07-15
560141718358705K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion DeviceMAX2016-07-14
560141507451439K160074Rampart D Lumbar Interbody Fusion DeviceMAX2016-10-18
560142035271903K153323Palisade Pedicular Fixation SystemNKB2016-02-23
560141412630239K152148Fortress Pedicular Fixation SystemNKB2015-09-02
560142031778839K143403Threshold Pedicular Fixation SystemNKB2014-12-18
560142006709288K142213VIA SPINOUS PROCESS FIXATION SYSTEMPEK2014-09-10
560141679120278K140010FORTRESS PEDICLE SCREW SYSTEMNKB2014-04-23
560141645050665K092464SPINEOLOGY FACET SCREWMRW2009-11-09
560141212388509K014200OPTIMESHEZX2003-11-26
560141767154209DEN200010Spineology Interbody Fusion SystemOQB2020-09-18
560141125268134
560141412966566
560141552288627
560141557664709
560141637799313

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB112017-08-21
MAX82021-02-19
OQB42025-12-15
OLO32025-12-04
OVD32019-08-23
PEK12014-09-10
MRW12009-11-09
EZX12003-11-26

PMN#

53 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next