3d Lumbar Cage

GUDID 08800065800575

FIMS.Co.,Ltd.

Metallic spinal interbody fusion cage

• Primary Device ID: 08800065800575
• NIH Device Record Key: cc2384b2-bd52-4a77-b1e1-f2aab50b2655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3d Lumbar Cage
• Version Model Number: PT0911264
• Company DUNS: 689845119
• Company Name: FIMS.Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800065800575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180347

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-02
• Device Publish Date: 2024-06-24

On-Brand Devices [3d Lumbar Cage]

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