TiWave L

GUDID 00818345026704

Ti3D CAGE, 10W x 28L x 11H, 15°, STRAIGHT

HT MEDICAL, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00818345026704
• NIH Device Record Key: 93541e2d-802c-40ce-9c9c-aed2b5beccc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiWave L
• Version Model Number: 23-LCX-2811
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 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
• 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	00818345026704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182210

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2021-04-29
• Device Publish Date: 2021-04-21

On-Brand Devices [TiWave L]

• 00818345024748: Ti3D CAGE, 10W x 30L x 6H, 0 DEG, STRAIGHT
• 00818345024731: Ti3D CAGE, 10W x 28L x 6H, 0 DEG, STRAIGHT
• 00818345024724: Ti3D CAGE, 10W x 25L x 6H, 0 DEG, STRAIGHT
• 00818345024717: Ti3D CAGE, 10W x 22L x 6H, 0 DEG, STRAIGHT
• 00818345024700: Ti3D CAGE, 10W x 20L x 6H, 0 DEG, STRAIGHT
• 00818345026766: Ti3D CAGE, 10W x 28L x 17H, 15°, STRAIGHT
• 00818345026759: Ti3D CAGE, 10W x 28L x 16H, 15°, STRAIGHT
• 00818345026742: Ti3D CAGE, 10W x 28L x 15H, 15°, STRAIGHT
• 00818345026735: Ti3D CAGE, 10W x 28L x 14H, 15°, STRAIGHT
• 00818345026728: Ti3D CAGE, 10W x 28L x 13H, 15°, STRAIGHT
• 00818345026711: Ti3D CAGE, 10W x 28L x 12H, 15°, STRAIGHT
• 00818345026704: Ti3D CAGE, 10W x 28L x 11H, 15°, STRAIGHT
• 00818345026698: Ti3D CAGE, 10W x 28L x 10H, 15°, STRAIGHT
• 00818345026681: Ti3D CAGE, 10W x 25L x 17H, 15°, STRAIGHT
• 00818345026674: Ti3D CAGE, 10W x 25L x 16H, 15°, STRAIGHT
• 00818345026667: Ti3D CAGE, 10W x 25L x 15H, 15°, STRAIGHT
• 00818345026650: Ti3D CAGE, 10W x 25L x 14H, 15°, STRAIGHT
• 00818345026643: Ti3D CAGE, 10W x 25L x 13H, 15°, STRAIGHT
• 00818345026636: Ti3D CAGE, 10W x 25L x 12H, 15°, STRAIGHT
• 00818345026629: Ti3D CAGE, 10W x 25L x 11H, 15°, STRAIGHT
• 00818345026612: Ti3D CAGE, 10W x 25L x 10H, 15°, STRAIGHT
• 00818345026605: Ti3D CAGE, 10W x 25L x 9H, 15°, STRAIGHT
• 00818345026599: Ti3D CAGE, 10W x 22L x 17H, 15°, STRAIGHT
• 00818345026582: Ti3D CAGE, 10W x 22L x 16H, 15°, STRAIGHT
• 00818345026575: Ti3D CAGE, 10W x 22L x 15H, 15°, STRAIGHT
• 00818345026568: Ti3D CAGE, 10W x 22L x 14H, 15°, STRAIGHT
• 00818345026551: Ti3D CAGE, 10W x 22L x 13H, 15°, STRAIGHT
• 00818345026544: Ti3D CAGE, 10W x 22L x 12H, 15°, STRAIGHT
• 00818345026537: Ti3D CAGE, 10W x 22L x 11H, 15°, STRAIGHT
• 00818345026520: Ti3D CAGE, 10W x 22L x 10H, 15°, STRAIGHT
• 00818345026513: Ti3D CAGE, 10W x 22L x 9H, 15°, STRAIGHT