Ti3D CERVICAL N/A

GUDID 00818345023741

NeoFuse Cervical Trials, 16W x 13D x 12H, 6 DEG

HT MEDICAL, LLC

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00818345023741
• NIH Device Record Key: 43458943-3f52-49c5-bd97-bbec737523f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti3D CERVICAL
• Version Model Number: B263-12
• Catalog Number: N/A
• Company DUNS: 080386764
• Company Name: HT MEDICAL, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@htmedicalusa.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
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• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00818345023741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170318

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

[00818345023741]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-06
• Device Publish Date: 2020-06-26

On-Brand Devices [Ti3D CERVICAL]

• 00818345023581: NeoFuse Cervical Trials, 12W x 11.5D x 12H, 6 DEG
• 00818345023574: NeoFuse Cervical Trials, 12W x 11.5D x 11H, 6 DEG
• 00818345023567: NeoFuse Cervical Trials, 12W x 11.5D x 10H, 6 DEG
• 00818345023550: NeoFuse Cervical Trials, 12W x 11.5D x 9H, 6 DEG
• 00818345023543: NeoFuse Cervical Trials, 12W x 11.5D x 8H, 6 DEG
• 00818345023536: NeoFuse Cervical Trials, 12W x 11.5D x 7H, 6 DEG
• 00818345023529: NeoFuse Cervical Trials, 12W x 11.5D x 6H, 6 DEG
• 00818345023512: NeoFuse Cervical Trials, 12W x 11.5D x 5H, 6 DEG
• 00818345023741: NeoFuse Cervical Trials, 16W x 13D x 12H, 6 DEG
• 00818345023734: NeoFuse Cervical Trials, 16W x 13D x 11H, 6 DEG
• 00818345023727: NeoFuse Cervical Trials, 16W x 13D x 10H, 6 DEG
• 00818345023710: NeoFuse Cervical Trials, 16W x 13D x 9H, 6 DEG
• 00818345023703: NeoFuse Cervical Trials, 16W x 13D x 8H, 6 DEG
• 00818345023697: NeoFuse Cervical Trials, 16W x 13D x 7H, 6 DEG
• 00818345023680: NeoFuse Cervical Trials, 16W x 13D x 6H, 6 DEG
• 00818345023673: NeoFuse Cervical Trials, 16W x 13D x 5H, 6 DEG
• 00818345023666: NeoFuse Cervical Trials, 14W x 12D x 12H, 6 DEG
• 00818345023659: NeoFuse Cervical Trials, 14W x 12D x 11H, 6 DEG
• 00818345023642: NeoFuse Cervical Trials, 14W x 12D x 10H, 6 DEG
• 00818345023635: NeoFuse Cervical Trials, 14W x 12D x 9H, 6 DEG
• 00818345023628: NeoFuse Cervical Trials, 14W x 12D x 8H, 6 DEG
• 00818345023611: NeoFuse Cervical Trials, 14W x 12D x 7H, 6 DEG
• 00818345023604: NeoFuse Cervical Trials, 14W x 12D x 6H, 6 DEG
• 00818345023598: NeoFuse Cervical Trials, 14W x 12D x 5H, 6 DEG
• 00818345023505: Modular Trial 16W x 13D x 12H, 6 DEG
• 00818345023499: Modular Trial 16W x 13D x 11H, 6 DEG
• 00818345023482: Modular Trial 16W x 13D x 10H, 6 DEG
• 00818345023475: Modular Trial 16W x 13D x 9H, 6 DEG
• 00818345023468: Modular Trial 16W x 13D x 8H, 6 DEG
• 00818345023451: Modular Trial 16W x 13D x 7H, 6 DEG
• 00818345023444: Modular Trial 16W x 13D x 6H, 6 DEG
• 00818345023437: Modular Trial 16W x 13D x 5H, 6 DEG
• 00818345023420: Modular Trial 14W x 12D x 12H, 6 DEG
• 00818345023413: Modular Trial 14W x 12D x 11H, 6 DEG
• 00818345023406: Modular Trial 14W x 12D x 10H, 6 DEG
• 00818345023390: Modular Trial 14W x 12D x 9H, 6 DEG
• 00818345023383: Modular Trial 14W x 12D x 8H, 6 DEG
• 00818345023376: Modular Trial 14W x 12D x 7H, 6 DEG
• 00818345023369: Modular Trial 14W x 12D x 6H, 6 DEG
• 00818345023352: Modular Trial 14W x 12D x 5H, 6 DEG
• 00818345023345: Modular Trial 12W x 11.5D x 12H, 6 DEG
• 00818345023338: Modular Trial 12W x 11.5D x 11H, 6 DEG
• 00818345023321: Modular Trial 12W x 11.5D x 10H, 6 DEG
• 00818345023314: Modular Trial 12W x 11.5D x 9H, 6 DEG
• 00818345023307: Modular Trial 12W x 11.5D x 8H, 6 DEG
• 00818345023291: Modular Trial 12W x 11.5D x 7H, 6 DEG
• 00818345023284: Modular Trial 12W x 11.5D x 6H, 6 DEG
• 00818345023277: Modular Trial 12W x 11.5D x 5H, 6 DEG
• 00818345027251: Universal Handle, Cervical, Double Sided
• 00818345023758: Universal Handle, Cervical, One Sided