Xpine Spinal Fixation System

GUDID 08800089441716

Jeil Medical Corporation

Spinal bone screw, non-bioabsorbable
Primary Device ID08800089441716
NIH Device Record Key0288b8de-208f-41cf-a9d2-3dc693bcf718
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpine Spinal Fixation System
Version Model NumberL69-RP60A-65100
Company DUNS688811603
Company NameJeil Medical Corporation
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800089441716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


[08800089441716]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-21
Device Publish Date2024-11-13

On-Brand Devices [Xpine Spinal Fixation System]

08800089439430L69-P60A-8095
08800089439423L69-P60A-8090
08800089439416L69-P60A-8085
08800089439409L69-P60A-8080
08800089439393L69-P60A-8075
08800089439386L69-P60A-8070
08800089439379L69-P60A-8065
08800089439362L69-P60A-8060
08800089439355L69-P60A-8055
08800089439348L69-P60A-8050
08800089439331L69-P60A-8045
08800089439324L69-P60A-8040
08800089439317L69-P60A-8035
08800089439300L69-P60A-8030
08800089439294L69-P60A-8025
08800089439287L69-P60A-8020
08800089439263L69-P60A-7595
08800089439256L69-P60A-7590
08800089439249L69-P60A-7585
08800089439232L69-P60A-7580
08800089439225L69-P60A-7575
08800089439218L69-P60A-7570
08800089439201L69-P60A-7565
08800089439195L69-P60A-7560
08800089439188L69-P60A-7555
08800089439171L69-P60A-7550
08800089439164L69-P60A-7545
08800089439157L69-P60A-7540
08800089439140L69-P60A-7535
08800089439133L69-P60A-7530
08800089439126L69-P60A-7525
08800089439119L69-P60A-7520
08800089439102L69-P60A-75100
08800089439096L69-P60A-7095
08800089439089L69-P60A-7090
08800089439072L69-P60A-7085
08800089439065L69-P60A-7080
08800089439058L69-P60A-7075
08800089439041L69-P60A-7070
08800089439034L69-P60A-7065
08800089439027L69-P60A-7060
08800089439010L69-P60A-7055
08800089439003L69-P60A-7050
08800089438990L69-P60A-7045
08800089438983L69-P60A-7040
08800089438976L69-P60A-7035
08800089438969L69-P60A-7030
08800089438952L69-P60A-7025
08800089438945L69-P60A-7020
08800089438938L69-P60A-70100

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