PathLoc-C Posterior Cervical Fixation System

GUDID 08806344307476

PathLoc-C Cervical MIS Screw(Open Type, Sleeve 50mm) 3.5x32mm 1EA

L&K BIOMED CO. ,LTD.

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Primary Device ID	08806344307476
NIH Device Record Key	c21fcc37-d34e-4c05-9535-c28514e5a359
Commercial Distribution Status	In Commercial Distribution
Brand Name	PathLoc-C Posterior Cervical Fixation System
Version Model Number	6315-3532
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	08806344307476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153439

FDA Product Code

NKG	Posterior Cervical Screw System