FDA Registration Active 🇳🇱 Netherlands

CD Perc Trauma

Reg #: 3002807561 · FEI: 3002807561 · Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6

Registration Details

Registration Name
MEDTRONIC B.V. (EOC)
Registration Number
3002807561
FEI Number
3002807561
Status
Active
Expiry Year
2025
Initial Importer
No
Address
EARL BAKKENSTRAAT 10
City
HEERLEN Limburg
Country
NL

Regulatory Submissions

510(k) Number
K052747

Owner / Operator

Firm Name
Medtronic, Inc.
Operator Number
2112641
Address
710 Medtronic Parkway
City
Minneapolis
State
MN
Postal Code
55432
Country
US

US Agent

Business Name
Medtronic Sofamor Danek USA, Inc. (Pyramid Place)
Contact Name
Michelle Obenauer
Address
1800 Pyramid Place
City
Memphis
State
TN
ZIP
38132
Country
US
Phone
901 3992117

Products

Device Name Product Code
Appliance, Fixation, Spinal Intervertebral Body KWQ
Appliance, Fixation, Spinal Interlaminal KWP
Thoracolumbosacral Pedicle Screw System NKB
Orthosis, Spondylolisthesis Spinal Fixation MNH
Orthosis, Spinal Pedicle Fixation MNI
Posterior Metal/Polymer Spinal System, Fusion NQP

Proprietary Names

CD Perc Trauma

Establishment Types

Export Device to the United States But Perform No Other Operation on Device