3d Lumbar Cage

GUDID 08800065800131

FIMS.Co.,Ltd.

Metallic spinal interbody fusion cage
Primary Device ID08800065800131
NIH Device Record Keyb5338e98-9d53-45dc-99c6-b69a44e85974
Commercial Distribution StatusIn Commercial Distribution
Brand Name3d Lumbar Cage
Version Model NumberPT1309264
Company DUNS689845119
Company NameFIMS.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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800065800131 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-13
Device Publish Date2024-11-05

On-Brand Devices [3d Lumbar Cage]

08800065800711PT1511268
08800065800704PT1411268
08800065800698PT1311268
08800065800681PT1211268
08800065800674PT1111268
08800065800667PT1011268
08800065800650PT0911268
08800065800643PT0811268
08800065800636PT1511264
08800065800629PT1411264
08800065800612PT1311264
08800065800605PT1211264
08800065800599PT1111264
08800065800582PT1011264
08800065800575PT0911264
08800065800568PT0811264
08800065808335TT1112324
08800065808328TT1012324
08800065808311TT0912324
08800065808304TT0812324
08800065834693PT0709264
08800065800087PT0809264
08800065800230PT1509268
08800065800223PT1409268
08800065800216PT1309268
08800065800209PT1209268
08800065800193PT1109268
08800065800186PT1009268
08800065800179PT0909268
08800065800162PT0809268
08800065800155PT1509264
08800065800148PT1409264
08800065800131PT1309264
08800065800124PT1209264
08800065800117PT1109264
08800065800100PT1009264
08800065800094PT0909264

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