Titan Spine, a Division of Medtronic

FDA Device Registration & Listing · Milwaukee, WI, US · Registration 3011577940

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
3011577940
FEI Number
3011577940
Entity Name
Titan Spine, a Division of Medtronic
City/State/Country
Milwaukee, WI, US
Establishment Address
8347 N Steven Rd, Milwaukee, WI 53223, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190840
PMA Number
N/A

All Registered Proprietary Names

NO 8 HEXALOBE STRAIGHT DRIVER MULTIPLE TWIST Drill; Introducer Tool MICRO-FRANCE BIT DRILLS DRILL BIT (ORTHOPEDIC MA Endoskeleton TCS Interbody Fusion Device CD Horizon ModuLeX Spinal System - Degen Scoli Phase 2 MULTIPLE (DRIVER-EXTRACTORS) IB3D™ PL Spinal System ELEVATOR CD Horizon Spinal System Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL Curette Endoskeleton TCS System TEMPLATE Medtronic Reusable Instrument IB3D™ PL Spinal System Adaptix™ Interbody System with Titan nanoLock™ Surface Technology ENDOSKELETON(R) TL INTERBODY FUSION DEVICE ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT ENDOSKELETON® TA nanoLOCK® Surface Technology ENDOSKELETON TO Rasp CD Horizon™ ModuLeX™ Spinal System Endoskeleton® TO ENDOSKELETON(R) TAS Endoskeleton(R) TCS System ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) SCREWDRIVER MULTIPLE (ORTHOPEDIC OSTEOTOMES) General Instrument PASS LP Spinal System Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device Endoskeleton TAS Plate ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD ENDOSKELETON® TL Medtronic Transportation_Sterilization Cassettes SHILLA™ Growth Guidance System Catalyft™ LS Expandable Interbody System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTX Rongeur Orthopedic Class 1 888.4540 2005-05-31
HTW Bit, Drill Orthopedic Class 1 888.4540 2006-06-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-09-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-04-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-04-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-04-22
HWB Extractor Orthopedic Class 1 888.4540 2005-05-31
HTE Elevator General, Plastic Surgery Class 1 878.4800 2005-05-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2011-01-06
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2011-01-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-01-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2011-01-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-01-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-01-06
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-04-19
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-05-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-05-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-05-07
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-05-07
HTF Curette General, Plastic Surgery Class 1 878.4800 2005-05-31
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-02-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-02-03
HWT Template Orthopedic Class 1 888.4800 2006-05-17
HWA Impactor Orthopedic Class 1 888.4540 2002-11-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-09-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-09-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-08-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2007-03-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-01-26
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-01-26
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-02
HTR Rasp General, Plastic Surgery Class 1 878.4800 2005-05-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-06-19
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2023-06-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-06-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-06-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-06-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-12-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-02
HXX Screwdriver Orthopedic Class 1 888.4540 1992-12-12
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2005-05-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-06-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-01-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2020-01-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-09-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-02
GXZ Electrode, Needle Neurology Class 2 882.1350 2016-08-23
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011577940. Last updated year: 2026. Please use registration number 3011577940 when referencing this establishment in official correspondence.
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