PathLoc-C Posterior Cervical Fixation System 6315-4012

GUDID 08806344307582

PathLoc-C Cervical MIS Screw(Open Type, Sleeve 50mm) 4.0x12mm 1EA

L&K BIOMED CO. ,LTD.

Spinal bone screw, non-bioabsorbable
Primary Device ID08806344307582
NIH Device Record Key8a2e7907-1db0-494a-be89-5811152e1238
Commercial Distribution StatusIn Commercial Distribution
Brand NamePathLoc-C Posterior Cervical Fixation System
Version Model Number6315-4012
Catalog Number6315-4012
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
GS108806344307582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

[08806344307582]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-06-24
Device Publish Date2016-07-27

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
08806344312685PathLoc-C Cervical MIS Rod(Curved) 3.5x110mm 1EA
08806344310131PathLoc-C Cervical MIS Screw(Close Type, Sleeve 50mm) 4.0x18mm 1EA
08806344309036PathLoc-C Cervical MIS Screw(Open Type, Sleeve 80mm) 4.0x50mm 1EA
08806344306929PathLoc-C Cervical MIS Screw(Open Type, Sleeve 30mm) 4.0x48mm 1EA
08806344306844PathLoc-C Cervical MIS Screw(Open Type, Sleeve 30mm) 4.0x32mm 1EA
08806344306592PathLoc-C Cervical MIS Screw(Open Type, Sleeve 30mm) 3.5x24mm 1EA
08806344306172PathLoc-C Cervical MIS Screw(Open Type, Sleeve 20mm) 3.5x24mm 1EA
08806344306448PathLoc-C Cervical MIS Screw(Open Type, Sleeve 20mm) 4.0x36mm 1EA
08806344306431PathLoc-C Cervical MIS Screw(Open Type, Sleeve 20mm) 4.0x34mm 1EA
08806344312739PathLoc-C Cervical MIS Set Screw 1EA
08806344312722PathLoc-C Cervical MIS Rod(Curved) 3.5x150mm 1EA
08806344312715PathLoc-C Cervical MIS Rod(Curved) 3.5x140mm 1EA
08806344312708PathLoc-C Cervical MIS Rod(Curved) 3.5x130mm 1EA
08806344312692PathLoc-C Cervical MIS Rod(Curved) 3.5x120mm 1EA
08806344312678PathLoc-C Cervical MIS Rod(Curved) 3.5x100mm 1EA
08806344312661PathLoc-C Cervical MIS Rod(Curved) 3.5x90mm 1EA
08806344312654PathLoc-C Cervical MIS Rod(Curved) 3.5x80mm 1EA
08806344312647PathLoc-C Cervical MIS Rod(Curved) 3.5x70mm 1EA
08806344312630PathLoc-C Cervical MIS Rod(Curved) 3.5x60mm 1EA
08806344312623PathLoc-C Cervical MIS Rod(Curved) 3.5x50mm 1EA
08806344312616PathLoc-C Cervical MIS Rod(Curved) 3.5x40mm 1EA
08806344312609PathLoc-C Cervical MIS Rod(Straight) 3.5x240mm 1EA
08806344312593PathLoc-C Cervical MIS Rod(Straight) 3.5x230mm 1EA
08806344312586PathLoc-C Cervical MIS Rod(Straight) 3.5x220mm 1EA
08806344312579PathLoc-C Cervical MIS Rod(Straight) 3.5x210mm 1EA
08806344312562PathLoc-C Cervical MIS Rod(Straight) 3.5x200mm 1EA
08806344312555PathLoc-C Cervical MIS Rod(Straight) 3.5x190mm 1EA
08806344312548PathLoc-C Cervical MIS Rod(Straight) 3.5x180mm 1EA
08806344312531PathLoc-C Cervical MIS Rod(Straight) 3.5x170mm 1EA
08806344312524PathLoc-C Cervical MIS Rod(Straight) 3.5x160mm 1EA
08806344312517PathLoc-C Cervical MIS Rod(Straight) 3.5x150mm 1EA
08806344312500PathLoc-C Cervical MIS Rod(Straight) 3.5x140mm 1EA
08806344312494PathLoc-C Cervical MIS Rod(Straight) 3.5x130mm 1EA
08806344312487PathLoc-C Cervical MIS Rod(Straight) 3.5x120mm 1EA
08806344312470PathLoc-C Cervical MIS Rod(Straight) 3.5x110mm 1EA
08806344312463PathLoc-C Cervical MIS Rod(Straight) 3.5x100mm 1EA
08806344312456PathLoc-C Cervical MIS Rod(Straight) 3.5x90mm 1EA
08806344312449PathLoc-C Cervical MIS Rod(Straight) 3.5x80mm 1EA
08806344312432PathLoc-C Cervical MIS Rod(Straight) 3.5x70mm 1EA
08806344312425PathLoc-C Cervical MIS Rod(Straight) 3.5x60mm 1EA
08806344312418PathLoc-C Cervical MIS Rod(Straight) 3.5x50mm 1EA
08806344312401PathLoc-C Cervical MIS Rod(Straight) 3.5x40mm 1EA
08806344312395PathLoc-C Cervical MIS Rod(Straight) 3.5x40mm 1EA
08806344312388PathLoc-C Cervical MIS Screw(Close Type, Sleeve 100mm) 4.0x48mm 1EA
08806344312029PathLoc-C Cervical MIS Screw(Close Type, Sleeve 100mm) 3.5x18mm 1EA
08806344311817PathLoc-C Cervical MIS Screw(Close Type, Sleeve 90mm) 4.0x18mm 1EA
08806344311756PathLoc-C Cervical MIS Screw(Close Type, Sleeve 90mm) 3.5x48mm 1EA
08806344311749PathLoc-C Cervical MIS Screw(Close Type, Sleeve 90mm) 3.5x46mm 1EA
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.