NeoFuse Ti3D CERVICAL

GUDID 00818345026773

Ti3D CAGE 14W x 12D x 4H, 6 DEG

HT MEDICAL, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00818345026773
• NIH Device Record Key: 96bc65aa-9e48-48c9-9c2b-5bd972c3f8f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoFuse Ti3D CERVICAL
• Version Model Number: C1412-04
• Company DUNS: 080386764
• Company Name: HT MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• 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: 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

Customer Support Contacts

• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.com
• Phone: 918-995-2090
• Email: customerservice@htspine.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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818345026773 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [NeoFuse Ti3D CERVICAL]

• 00818345020986: Ti3D CAGE 16W x 14D x12H, 6 DEG
• 00818345020979: Ti3D CAGE 16W x 14D x11H, 6 DEG
• 00818345020962: Ti3D CAGE 16W x 14D x10H, 6 DEG
• 00818345020955: Ti3D CAGE 16W x 14D x9H, 6 DEG
• 00818345020948: Ti3D CAGE 16W x 14D x8H, 6 DEG
• 00818345020931: Ti3D CAGE 16W x 14D x7H, 6 DEG
• 00818345020924: Ti3D CAGE 16W x 14D x6H, 6 DEG
• 00818345020917: Ti3D CAGE 16W x 14D x5H, 6 DEG
• 00818345020900: Ti3D CAGE 14W x 12D x12H, 6 DEG
• 00818345020894: Ti3D CAGE 14W x 12D x11H, 6 DEG
• 00818345020887: Ti3D CAGE 14W x 12D x10H, 6 DEG
• 00818345020870: Ti3D CAGE 14W x 12D x9H, 6 DEG
• 00818345020863: Ti3D CAGE 14W x 12D x8H, 6 DEG
• 00818345020856: Ti3D CAGE 14W x 12D x7H, 6 DEG
• 00818345020849: Ti3D CAGE 14W x 12D x6H, 6 DEG
• 00818345020832: Ti3D CAGE 14W x 12D x5H, 6 DEG
• 00818345020825: Ti3D CAGE 12W x 11.5D x12H, 6 DEG
• 00818345020818: Ti3D CAGE 12W x 11.5D x11H, 6 DEG
• 00818345020801: Ti3D CAGE 12W x 11.5D x10H, 6 DEG
• 00818345020795: Ti3D CAGE 12W x 11.5D x9H, 6 DEG
• 00818345020788: Ti3D CAGE 12W x 11.5D x8H, 6 DEG
• 00818345020771: Ti3D CAGE 12W x 11.5D x7H, 6 DEG
• 00818345020764: Ti3D CAGE 12W x 11.5D x6H, 6 DEG
• 00818345020757: Ti3D CAGE 12W x 11.5D x5H, 6 DEG
• 00818345023239: Ti3D CAGE 16W x 13D x 12H, 6 DEG
• 00818345023222: Ti3D CAGE 16W x 13D x 11H, 6 DEG
• 00818345023215: Ti3D CAGE 16W x 13D x 10H, 6 DEG
• 00818345023208: Ti3D CAGE 16W x 13D x 9H, 6 DEG
• 00818345023192: Ti3D CAGE 16W x 13D x 8H, 6 DEG
• 00818345023185: Ti3D CAGE 16W x 13D x 7H, 6 DEG
• 00818345023178: Ti3D CAGE 16W x 13D x 6H, 6 DEG
• 00818345023161: Ti3D CAGE 16W x 13D x 5H, 6 DEG
• 00818345026032: Ti3D CAGE 12W x 11.5D x 4H, 6 DEG
• 00818345026773: Ti3D CAGE 14W x 12D x 4H, 6 DEG
• 00818345026780: NeoFuse Cervical Trial, 14Wx12Dx4H, 6 deg