Ti3D Straight Lumbar

GUDID 00818345024588

Ti3D Lumbar Trial, Straight Oblique, 25x10mm, 7mm, 8 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 ID00818345024588
NIH Device Record Key1f6fd8dd-2a97-4961-a6dc-e79c8cc7f3bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi3D Straight Lumbar
Version Model Number23-LTT-2507
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
GS100818345024588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

Moist Heat or Steam Sterilization

[00818345024588]

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 [Ti3D Straight Lumbar]

00818345024564Ti3D CAGE, 10W x 28L x 17H, 8 DEG, STRAIGHT
00818345024557Ti3D CAGE, 10W x 28L x 16H, 8 DEG, STRAIGHT
00818345024540Ti3D CAGE, 10W x 28L x 15H, 8 DEG, STRAIGHT
00818345024533Ti3D CAGE, 10W x 28L x 14H, 8 DEG, STRAIGHT
00818345024526Ti3D CAGE, 10W x 28L x 13H, 8 DEG, STRAIGHT
00818345024519Ti3D CAGE, 10W x 28L x 12H, 8 DEG, STRAIGHT
00818345024502Ti3D CAGE, 10W x 28L x 11H, 8 DEG, STRAIGHT
00818345024496Ti3D CAGE, 10W x 28L x 10H, 8 DEG, STRAIGHT
00818345024489Ti3D CAGE, 10W x 28L x 9H, 8 DEG, STRAIGHT
00818345024472Ti3D CAGE, 10W x 28L x 8H, 8 DEG, STRAIGHT
00818345024465Ti3D CAGE, 10W x 25L x 17H, 8 DEG, STRAIGHT
00818345024458Ti3D CAGE, 10W x 25L x 16H, 8 DEG, STRAIGHT
00818345024441Ti3D CAGE, 10W x 25L x 15H, 8 DEG, STRAIGHT
00818345024434Ti3D CAGE, 10W x 25L x 14H, 8 DEG, STRAIGHT
00818345024427Ti3D CAGE, 10W x 25L x 13H, 8 DEG, STRAIGHT
00818345024410Ti3D CAGE, 10W x 25L x 12H, 8 DEG, STRAIGHT
00818345024403Ti3D CAGE, 10W x 25L x 11H, 8 DEG, STRAIGHT
00818345024397Ti3D CAGE, 10W x 25L x 10H, 8 DEG, STRAIGHT
00818345024380Ti3D CAGE, 10W x 25L x 9H, 8 DEG, STRAIGHT
00818345024373Ti3D CAGE, 10W x 25L x 8H, 8 DEG, STRAIGHT
00818345024366Ti3D CAGE, 10W x 25L x 7H, 8 DEG, STRAIGHT
00818345024359Ti3D CAGE, 10W x 22L x 17H, 8 DEG, STRAIGHT
00818345024342Ti3D CAGE, 10W x 22L x 16H, 8 DEG, STRAIGHT
00818345024335Ti3D CAGE, 10W x 22L x 15H, 8 DEG, STRAIGHT
00818345024328Ti3D CAGE, 10W x 22L x 14H, 8 DEG, STRAIGHT
00818345024311Ti3D CAGE, 10W x 22L x 13H, 8 DEG, STRAIGHT
00818345024304Ti3D CAGE, 10W x 22L x 12H, 8 DEG, STRAIGHT
00818345024298Ti3D CAGE, 10W x 22L x 11H, 8 DEG, STRAIGHT
00818345024281Ti3D CAGE, 10W x 22L x 10H, 8 DEG, STRAIGHT
00818345024274Ti3D CAGE, 10W x 22L x 9H, 8 DEG, STRAIGHT
00818345024267Ti3D CAGE, 10W x 22L x 8H, 8 DEG, STRAIGHT
00818345024250Ti3D CAGE, 10W x 22L x 7H, 8 DEG, STRAIGHT
00818345024007PADDLE SPREADER, 17MM
00818345023994PADDLE SPREADER, 16MM
00818345023987PADDLE SPREADER, 15MM
00818345023970PADDLE SPREADER, 14MM
00818345023963PADDLE SPREADER, 13MM
00818345023956PADDLE SPREADER, 12MM
00818345023949PADDLE SPREADER, 11MM
00818345023932PADDLE SPREADER, 10MM
00818345023925PADDLE SPREADER, 9MM
00818345023918PADDLE SPREADER, 8MM
00818345023901PADDLE SPREADER, 7MM
00818345023895PADDLE SPREADER, 6MM
00818345024113Paddle Shaver, 16mm
00818345024106Paddle Shaver, 15mm
00818345024090Paddle Shaver, 14mm
00818345024083Paddle Shaver, 13mm
00818345024076Paddle Shaver, 12mm
00818345024069Paddle Shaver, 11mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.