107-018-7040

GUDID 04250869603263

MOSS Ti Pedicle Screw, Ø7.0x40mm DL, violet

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	04250869603263
NIH Device Record Key	04e7b106-e807-4572-9a4e-6250a30ad956
Commercial Distribution Status	In Commercial Distribution
Version Model Number	107-018-7040
Catalog Number	107-018-7040
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	04250869603263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162232

FDA Product Code

NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease