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 ID08806344307476
NIH Device Record Keyc21fcc37-d34e-4c05-9535-c28514e5a359
Commercial Distribution StatusIn Commercial Distribution
Brand NamePathLoc-C Posterior Cervical Fixation System
Version Model Number6315-3532
Company DUNS631159324
Company NameL&K BIOMED CO. ,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]
GS108806344307476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System
NKGPosterior Cervical Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


[08806344307476]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [PathLoc-C Posterior Cervical Fixation System]

08806344307803PathLoc-C Cervical MIS Screw(Open Type, Sleeve 60mm) 3.5x14mm 1EA
08806344307476PathLoc-C Cervical MIS Screw(Open Type, Sleeve 50mm) 3.5x32mm 1EA

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