FDA Registration
Active
🇩🇪 Germany
MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
Reg #: 3011795235
·
FEI: 3011795235
·
Expires 2026
Products
23
Proprietary Names
82
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
- Registration Number
- 3011795235
- FEI Number
- 3011795235
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ULRICHSBERGERSTR. 17
- City
- DEGGENDORF Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K090353
- PMA Number
- P000058
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2009-11-03 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2011-10-31 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2010-11-10 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2008-06-05 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-05-06 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2008-02-01 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2020-10-14 |
| Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction | NEK | Class 3 | Unknown | No | 2008-03-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2009-09-01 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2009-09-01 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2009-09-01 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2009-09-01 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2009-09-01 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2013-06-13 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2008-02-01 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1992-12-12 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2005-03-23 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2019-10-18 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2017-11-21 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-03-16 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-06-29 |
| Probe | HXB | Class 1 | Orthopedic | No | 2006-06-29 |
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
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
Verte-Stack Modified Cornerstone
VERTE-STACK(TM)SPINAL SYSTEM
DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
RETRACTOR
RadiaLux
Spacekeeper
Verte-Stack Crescent
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
IB3D PL Spinal System
INFINITY OCT System
STEALTH AXIS
Peek Rod
CAPSTONE PTC SPINAL SYSTEM
DIVERGENCE(TM) Anterior Cervical Fusion System
Tray, Surgical, Instrument
instrument tray
Aspen
Bard-Parker
Wire Nest
Verte-Stack Clydesdale
SOVEREIGN SPINAL SYSTEM
Vete-Stack Modified
CEMENT
VERTEBROPLASTY
DIVERGENCE Anterior Cervical Fusion System
General Instrument
PASS LP Spinal System
Perimiter C
PROBE (ORTHOPEDIC MANU
CD Horizon ModuLeX Spinal System
MASTERGRAFT(TM) BONE VOID FILLER
Verte-Stack Capstone Peek
Establishment Types
Manufacture Medical Device