108-018-8045

GUDID 04250869610698

MOSS VRS Ti Pedicle Screw Ø8.0x45mm, DL, polyaxial, gold

Biedermann Motech GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

Primary Device ID	04250869610698
NIH Device Record Key	54528d7a-d3dd-4148-876c-5c7f7d966589
Commercial Distribution Status	In Commercial Distribution
Version Model Number	108-018-8045
Catalog Number	108-018-8045
Company DUNS	320249162
Company Name	Biedermann Motech GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250869610698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181821

FDA Product Code

NKB	Thoracolumbosacral pedicle screw system