4CIS VANE SPINE SYSTEM 4302-5530

GUDID 08806373590382

Spinal Rigid Rod, Ø5.5x300mm

SOLCO BIOMEDICAL CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	08806373590382
NIH Device Record Key	d24ae695-0a74-4e56-b028-ad0072a215a8
Commercial Distribution Status	In Commercial Distribution
Brand Name	4CIS VANE SPINE SYSTEM
Version Model Number	4302-5530
Catalog Number	4302-5530
Company DUNS	687844241
Company Name	SOLCO BIOMEDICAL CO.,LTD.
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	true
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	08806373590382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K081145

FDA Product Code

MNH	Orthosis, Spondylolisthesis Spinal Fixation