SPINEOLOGY INC.

FDA Device Registration & Listing · Saint Paul, MN, US · Registration 2135156

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2135156
FEI Number
3003179719
Entity Name
SPINEOLOGY INC.
City/State/Country
Saint Paul, MN, US
Establishment Address
7800 THIRD STREET N., SUITE 600, Saint Paul, MN 55128, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Spineology Inc (Owner Number: 9036813)
Owner / Operator Contact Address
7800 Third ST. N., Suite 600, Saint Paul, MN 55128, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182322
PMA Number
N/A

All Registered Proprietary Names

Duo Lumbar Interbody Fusion Device OptiMesh Expandable Interbody Fusion System Rampart One Lumbar Interbody Fusion System Duo Ti Expandable Interbody Fusion System Rampart O Lumbar Interbody Fusion Device Fortress Pedicular Fixation System ConneX Connectors Threshold V2 Pedicular Fixation System OptiMesh Multiplanar Expandable Interbody Fusion System Surgical Instruments Rampart One Lumbar Interbody Fusion Device Capture Facet Fixation System Spineology Navigation Instruments Duo Lumbar Interbody Fusion Device Elite Expandable Interbody Fusion System OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System Powered Brushes SOAR Retractor System Medius Midline Retractor System Merlon Retractor System Surgical Instruments Rampart One Lumbar Interbody Fusion System Fortress Pedicular Fixation System Threshold V2 Pedicular Fixation System Threshold Pedicular Fixation System Palisade Pedicular Fixation System Threshold V2 Pedicular Fixation System Palisade Pedicular Fixation System Duo Lumbar Interbody Fusion Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-11-19
OQB Intervertebral Body Graft Containment Device Orthopedic Class 2 888.3085 2021-03-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-10-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-10-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-11-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-06-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-06-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-06-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-04-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-04-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-04-17
OQB Intervertebral Body Graft Containment Device Orthopedic Class 2 888.3085 2023-12-26
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2013-11-21
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-05-11
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2009-11-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-11-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-11-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-01-30
OQB Intervertebral Body Graft Containment Device Orthopedic Class 2 888.3085 2025-12-16
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-10-07
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-11-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2001-03-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-05-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-08-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-07-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-07-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-07-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-06-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spineology Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

Similar Registrations

Registration Number Establishment Name Location
3021588295 XYRESIC LLC Jackson, MI, US
3017936978 CARLSMED, INC. Carlsbad, CA, US
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
2134947 GAUTHIER BIOMEDICAL, INC. Grafton, WI, US
1526534 Sterigenics US, LLC Lewis Center, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2135156. Last updated year: 2026. Please use registration number 2135156 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.