restor3d Cervical Cage

GUDID 00840097500751

Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx8Hx7

Restor3d

Metallic spinal interbody fusion cage

• Primary Device ID: 00840097500751
• NIH Device Record Key: 6859e462-74e9-4f99-9ddf-fc70d9a56496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Cervical Cage
• Version Model Number: 1110-17150807
• Company DUNS: 080819836
• Company Name: Restor3d
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097500751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191812

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

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: 2021-03-25
• Device Publish Date: 2021-03-17

On-Brand Devices [restor3d Cervical Cage ]

• 00840097502458: Titanium (Ti-6Al-4V) Cervical Cage 001, 17Wx15Dx12Hx7
• 00840097502441: Titanium (Ti-6Al-4V) Cervical Cage 001, 17Wx15Dx11Hx7
• 00840097502434: Titanium (Ti-6Al-4V) Cervical Cage 001, 17Wx15Dx10Hx7
• 00840097502427: Titanium (Ti-6Al-4V) Cervical Cage 001, 17Wx15Dx9Hx7
• 00840097502410: Titanium (Ti-6Al-4V) Cervical Cage 001, 17Wx15Dx8Hx7
• 00840097502403: Titanium (Ti-6Al-4V) Cervical Cage 001, 17Wx15Dx7Hx7
• 00840097502397: Titanium (Ti-6Al-4V) Cervical Cage 001, 16Wx13Dx12Hx7
• 00840097502380: Titanium (Ti-6Al-4V) Cervical Cage 001, 16Wx13Dx11Hx7
• 00840097502373: Titanium (Ti-6Al-4V) Cervical Cage 001, 16Wx13Dx10Hx7
• 00840097502366: Titanium (Ti-6Al-4V) Cervical Cage 001, 16Wx13Dx9Hx7
• 00840097502359: Titanium (Ti-6Al-4V) Cervical Cage 001, 16Wx13Dx8Hx7
• 00840097502342: Titanium (Ti-6Al-4V) Cervical Cage 001, 14Wx11Dx12Hx7
• 00840097502335: Titanium (Ti-6Al-4V) Cervical Cage 001, 16Wx13Dx7Hx7
• 00840097502328: Titanium (Ti-6Al-4V) Cervical Cage 001, 14Wx11Dx11Hx7
• 00840097502311: Titanium (Ti-6Al-4V) Cervical Cage 001, 14Wx11Dx10Hx7
• 00840097502304: Titanium (Ti-6Al-4V) Cervical Cage 001, 14Wx11Dx9Hx7
• 00840097502298: Titanium (Ti-6Al-4V) Cervical Cage 001, 14Wx11Dx8Hx7
• 00840097502281: Titanium (Ti-6Al-4V) Cervical Cage 001, 14Wx11Dx7Hx7
• 00840097500836: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx12Hx7
• 00840097500829: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx12Hx0
• 00840097500812: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx11Hx7
• 00840097500805: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx11Hx0
• 00840097500799: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx10Hx7
• 00840097500782: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx10Hx0
• 00840097500775: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx9Hx7
• 00840097500768: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx9Hx0
• 00840097500751: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx8Hx7
• 00840097500744: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx8Hx0
• 00840097500737: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx7Hx7
• 00840097500720: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx7Hx0
• 00840097500713: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx6Hx7
• 00840097500706: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx6Hx0
• 00840097500690: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx5Hx7
• 00840097500683: Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx5Hx0
• 00840097500676: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx12Hx7
• 00840097500669: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx12Hx0
• 00840097500652: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx11Hx7
• 00840097500645: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx11Hx0
• 00840097500638: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx10Hx7
• 00840097500621: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx10Hx0
• 00840097500614: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx9Hx7
• 00840097500607: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx9Hx0
• 00840097500591: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx8Hx7
• 00840097500584: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx8Hx0
• 00840097500577: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx7Hx7
• 00840097500560: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx7Hx0
• 00840097500553: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx6Hx7
• 00840097500546: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx6Hx0
• 00840097500539: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx05Hx7
• 00840097500522: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx05Hx0