MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH

FDA Device Registration & Listing · DEGGENDORF Bavaria, DE · Registration 3011795235

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
3011795235
FEI Number
3011795235
Entity Name
MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
City/State/Country
DEGGENDORF Bavaria, DE
Establishment Address
ULRICHSBERGERSTR. 17, DEGGENDORF Bavaria 94469, DE
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
K121760
PMA Number
N/A

All Registered Proprietary Names

PERIMETER Interbody Fusion Device Sovereign Mastergraft Mini Granules PEEK Previal Cervical Interbody Dev CLYDESDALE Spinal System Anatomic Peek PTC Cervical Fusion System Cage Verte-Stack XS Medtronic Transportation_Sterilization Cassettes SHILLA™ Growth Guidance System Catalyft™ LS Expandable Interbody System Verte-Stack Perimeter Peek PEEK Prevail Cervical Interbody Dev Capstone Control Verte-Stack T-Peek INFUSE BONEGRAFT/ LT-CAGE Lumbar TF TSRH Osteogrip CRESCENT™ SPINAL SYSTEM TITANIUM ELEVATE™ SPINAL SYSTEM CRESCENT™ SPINAL SYSTEM CAPSTONE PTC™ SPINAL SYSTEM LT CAGE PEEK INTERFIX Device (TIBFD) Spinal System CLYDESDALE Spinal System SOVEREIGN Spinal System VERTEX® Reconstruction System CD HORIZON® Spinal System Mastergraft ( UltraMatrix, Matrix EXT) Cement Restrictor Material Peek spinal system Verte-Stack Cornerstone Sm End Caps CAPSTONE Spinal System SCREWDRIVER mastergraft Clydesdale Spinal System CORNERSTONE PSR Cervical Fusion System CAPSTONE Spinal System Verte-Stack Modified Cornerstone VERTE-STACK(TM)SPINAL SYSTEM DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM RETRACTOR RadiaLux™ Spacekeeper Verte-Stack Crescent VERTEX® Reconstruction System CD HORIZON® Spinal System PIVOX" Oblique Lateral Spinal System Verte-Stack Perimeter XS VERTE-STACK Spinal System CAPSTONE-L SPINAL SYSTEM HourGlass Vertebral Body Spacer CAPSTONE CONTROL Spinal System CAPSTONE CONTROL PTC Spinal System Verte-Stack Modified Center Piece Crescent Spinal System Interbody F CORNERSTONEPSR Spinal System Anatomic Peek Soveriegn Spinal System Capstone Control™ Spinal System Verte-Stack Capstone L CD Horizon™ Astute™ Spinal System CRESCENT Vertebral Body Spacer spinal system

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 2009-11-03
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2011-10-31
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2010-11-10
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2008-06-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2009-02-05
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-05-06
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2010-07-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-06-06
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown Class 3 N/A 2008-03-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-09-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-09-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2009-09-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-09-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-09-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2002-10-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2008-04-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2009-11-19
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2013-06-13
JDK Prosthesis, Hip, Cement Restrictor General, Plastic Surgery Class 2 878.3300 2008-02-01
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2012-06-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-01-24
HXX Screwdriver Orthopedic Class 1 888.4540 1992-12-12
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2009-05-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-01-05
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2011-10-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2008-05-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2006-03-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-06-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-06-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-06-23
GAD Retractor General, Plastic Surgery Class 1 878.4800 2005-03-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-01-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-01-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-08-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-07-17
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-11-06
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2010-05-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2010-07-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-01-05
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2012-08-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-05-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-10-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-10-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-10-18
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2019-10-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-08-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-09-24

Official Correspondent

No official correspondent registered.

US Agent Details

Michelle Obenauer Email: michelle.obenauer@medtronic.com Phone: (901) 3992117

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

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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
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

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 3011795235. Last updated year: 2026. Please use registration number 3011795235 when referencing this establishment in official correspondence.
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