TiWave L

GUDID 00818345026537

Ti3D CAGE, 10W x 22L x 11H, 15°, STRAIGHT

HT MEDICAL, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00818345026537
• NIH Device Record Key: 8952d79a-6721-4f21-bc64-291eb9719651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiWave L
• Version Model Number: 23-LCX-2211
• 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
• 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	00818345026537 [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