NeoFuse Ti3D Cervical

GUDID 00818345026780

NeoFuse Cervical Trial, 14Wx12Dx4H, 6 deg

HT MEDICAL, LLC

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device ID00818345026780
NIH Device Record Key4b24217f-87aa-424a-95c8-b616ff9763eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoFuse Ti3D Cervical
Version Model NumberB242-04
Company DUNS080386764
Company NameHT MEDICAL, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com
Phone888-594-8633
Emailcs@xenixmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100818345026780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

[00818345026780]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-10
Device Publish Date2021-12-31

On-Brand Devices [NeoFuse Ti3D Cervical]

00818345020986Ti3D CAGE 16W x 14D x12H, 6 DEG
00818345020979Ti3D CAGE 16W x 14D x11H, 6 DEG
00818345020962Ti3D CAGE 16W x 14D x10H, 6 DEG
00818345020955Ti3D CAGE 16W x 14D x9H, 6 DEG
00818345020948Ti3D CAGE 16W x 14D x8H, 6 DEG
00818345020931Ti3D CAGE 16W x 14D x7H, 6 DEG
00818345020924Ti3D CAGE 16W x 14D x6H, 6 DEG
00818345020917Ti3D CAGE 16W x 14D x5H, 6 DEG
00818345020900Ti3D CAGE 14W x 12D x12H, 6 DEG
00818345020894Ti3D CAGE 14W x 12D x11H, 6 DEG
00818345020887Ti3D CAGE 14W x 12D x10H, 6 DEG
00818345020870Ti3D CAGE 14W x 12D x9H, 6 DEG
00818345020863Ti3D CAGE 14W x 12D x8H, 6 DEG
00818345020856Ti3D CAGE 14W x 12D x7H, 6 DEG
00818345020849Ti3D CAGE 14W x 12D x6H, 6 DEG
00818345020832Ti3D CAGE 14W x 12D x5H, 6 DEG
00818345020825Ti3D CAGE 12W x 11.5D x12H, 6 DEG
00818345020818Ti3D CAGE 12W x 11.5D x11H, 6 DEG
00818345020801Ti3D CAGE 12W x 11.5D x10H, 6 DEG
00818345020795Ti3D CAGE 12W x 11.5D x9H, 6 DEG
00818345020788Ti3D CAGE 12W x 11.5D x8H, 6 DEG
00818345020771Ti3D CAGE 12W x 11.5D x7H, 6 DEG
00818345020764Ti3D CAGE 12W x 11.5D x6H, 6 DEG
00818345020757Ti3D CAGE 12W x 11.5D x5H, 6 DEG
00818345023239Ti3D CAGE 16W x 13D x 12H, 6 DEG
00818345023222Ti3D CAGE 16W x 13D x 11H, 6 DEG
00818345023215Ti3D CAGE 16W x 13D x 10H, 6 DEG
00818345023208Ti3D CAGE 16W x 13D x 9H, 6 DEG
00818345023192Ti3D CAGE 16W x 13D x 8H, 6 DEG
00818345023185Ti3D CAGE 16W x 13D x 7H, 6 DEG
00818345023178Ti3D CAGE 16W x 13D x 6H, 6 DEG
00818345023161Ti3D CAGE 16W x 13D x 5H, 6 DEG
00818345026032Ti3D CAGE 12W x 11.5D x 4H, 6 DEG
00818345026773Ti3D CAGE 14W x 12D x 4H, 6 DEG
00818345026780NeoFuse Cervical Trial, 14Wx12Dx4H, 6 deg
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.