FIX-C 3D Ti ACIF System

GUDID 08800089453375

Jeil Medical Corporation

Metallic spinal interbody fusion cage
Primary Device ID08800089453375
NIH Device Record Key9c6d86cc-eeaf-46ac-9bec-a46011acd632
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIX-C 3D Ti ACIF System
Version Model NumberC73-001112-05
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
GS108800089453375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


[08800089453375]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-11
Device Publish Date2025-03-03

On-Brand Devices [FIX-C 3D Ti ACIF System]

08800089453597C73-001516-11
08800089453580C73-001516-10
08800089453573C73-001516-09
08800089453566C73-001516-08
08800089453559C73-001516-07
08800089453542C73-001516-06
08800089453535C73-001516-05
08800089453528C73-001516-04
08800089453511C73-001314-11
08800089453504C73-001314-10
08800089453498C73-001314-09
08800089453481C73-001314-08
08800089453474C73-001314-07
08800089453467C73-001314-06
08800089453450C73-001314-05
08800089453443C73-001314-04
08800089453436C73-001112-11
08800089453429C73-001112-10
08800089453412C73-001112-09
08800089453405C73-001112-08
08800089453399C73-001112-07
08800089453382C73-001112-06
08800089453375C73-001112-05
08800089453368C73-001112-04
08800089453351C73-051516-11
08800089453344C73-051516-10
08800089453337C73-051516-09
08800089453320C73-051516-08
08800089453313C73-051516-07
08800089453306C73-051516-06
08800089453290C73-051516-05
08800089453283C73-051516-04
08800089453276C73-051314-11
08800089453269C73-051314-10
08800089453252C73-051314-09
08800089453245C73-051314-08
08800089453238C73-051314-07
08800089453221C73-051314-06
08800089453214C73-051314-05
08800089453207C73-051314-04
08800089453191C73-051112-11
08800089453184C73-051112-10
08800089453177C73-051112-09
08800089453160C73-051112-08
08800089453153C73-051112-07
08800089453146C73-051112-06
08800089453139C73-051112-05
08800089453122C73-051112-04
08800089453115C73-071516-11
08800089453108C73-071516-10

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