TranS1 Anterior Cervical Plate System

GUDID 08806344363175

Variable Cervical Plate Screw, Self Drilling, Hex, Cylindrical, ∅ 3.5, 16mm

L&K BIOMED CO. ,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

Primary Device ID	08806344363175
NIH Device Record Key	e8915381-2d0b-44db-a76b-ea6e6592ef30
Commercial Distribution Status	In Commercial Distribution
Brand Name	TranS1 Anterior Cervical Plate System
Version Model Number	6504-3516
Company DUNS	631159324
Company Name	L&K BIOMED 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	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806344363175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K143279

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body