Ti3D CERVICAL N/A

GUDID 00818345023628

NeoFuse Cervical Trials, 14W x 12D x 8H, 6 DEG

HT MEDICAL, LLC

Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable 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 ID00818345023628
NIH Device Record Keyae7be497-5cea-44cd-8ffd-8a51b4b538de
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi3D CERVICAL
Version Model NumberB242-08
Catalog NumberN/A
Company DUNS080386764
Company NameHT MEDICAL, LLC
Device Count1
DM Exemptfalse
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@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.com
Phone888-594-8633
Emailcs@htmedicalusa.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
GS100818345023628 [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

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

[00818345023628]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-06
Device Publish Date2020-06-26

On-Brand Devices [Ti3D CERVICAL]

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