Ti3D Straight Lumbar N/A

GUDID 00818345024311

Ti3D CAGE, 10W x 22L x 13H, 8 DEG, STRAIGHT

HT MEDICAL, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00818345024311
• NIH Device Record Key: 8d8f76fb-1b25-4c8b-82aa-85549d2e82b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti3D Straight Lumbar
• Version Model Number: 23-LCT-2213
• Catalog Number: N/A
• Company DUNS: 080386764
• Company Name: HT MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• 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@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	00818345024311 [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: 2020-07-06
• Device Publish Date: 2020-06-26

On-Brand Devices [Ti3D Straight Lumbar]

• 00818345024564: Ti3D CAGE, 10W x 28L x 17H, 8 DEG, STRAIGHT
• 00818345024557: Ti3D CAGE, 10W x 28L x 16H, 8 DEG, STRAIGHT
• 00818345024540: Ti3D CAGE, 10W x 28L x 15H, 8 DEG, STRAIGHT
• 00818345024533: Ti3D CAGE, 10W x 28L x 14H, 8 DEG, STRAIGHT
• 00818345024526: Ti3D CAGE, 10W x 28L x 13H, 8 DEG, STRAIGHT
• 00818345024519: Ti3D CAGE, 10W x 28L x 12H, 8 DEG, STRAIGHT
• 00818345024502: Ti3D CAGE, 10W x 28L x 11H, 8 DEG, STRAIGHT
• 00818345024496: Ti3D CAGE, 10W x 28L x 10H, 8 DEG, STRAIGHT
• 00818345024489: Ti3D CAGE, 10W x 28L x 9H, 8 DEG, STRAIGHT
• 00818345024472: Ti3D CAGE, 10W x 28L x 8H, 8 DEG, STRAIGHT
• 00818345024465: Ti3D CAGE, 10W x 25L x 17H, 8 DEG, STRAIGHT
• 00818345024458: Ti3D CAGE, 10W x 25L x 16H, 8 DEG, STRAIGHT
• 00818345024441: Ti3D CAGE, 10W x 25L x 15H, 8 DEG, STRAIGHT
• 00818345024434: Ti3D CAGE, 10W x 25L x 14H, 8 DEG, STRAIGHT
• 00818345024427: Ti3D CAGE, 10W x 25L x 13H, 8 DEG, STRAIGHT
• 00818345024410: Ti3D CAGE, 10W x 25L x 12H, 8 DEG, STRAIGHT
• 00818345024403: Ti3D CAGE, 10W x 25L x 11H, 8 DEG, STRAIGHT
• 00818345024397: Ti3D CAGE, 10W x 25L x 10H, 8 DEG, STRAIGHT
• 00818345024380: Ti3D CAGE, 10W x 25L x 9H, 8 DEG, STRAIGHT
• 00818345024373: Ti3D CAGE, 10W x 25L x 8H, 8 DEG, STRAIGHT
• 00818345024366: Ti3D CAGE, 10W x 25L x 7H, 8 DEG, STRAIGHT
• 00818345024359: Ti3D CAGE, 10W x 22L x 17H, 8 DEG, STRAIGHT
• 00818345024342: Ti3D CAGE, 10W x 22L x 16H, 8 DEG, STRAIGHT
• 00818345024335: Ti3D CAGE, 10W x 22L x 15H, 8 DEG, STRAIGHT
• 00818345024328: Ti3D CAGE, 10W x 22L x 14H, 8 DEG, STRAIGHT
• 00818345024311: Ti3D CAGE, 10W x 22L x 13H, 8 DEG, STRAIGHT
• 00818345024304: Ti3D CAGE, 10W x 22L x 12H, 8 DEG, STRAIGHT
• 00818345024298: Ti3D CAGE, 10W x 22L x 11H, 8 DEG, STRAIGHT
• 00818345024281: Ti3D CAGE, 10W x 22L x 10H, 8 DEG, STRAIGHT
• 00818345024274: Ti3D CAGE, 10W x 22L x 9H, 8 DEG, STRAIGHT
• 00818345024267: Ti3D CAGE, 10W x 22L x 8H, 8 DEG, STRAIGHT
• 00818345024250: Ti3D CAGE, 10W x 22L x 7H, 8 DEG, STRAIGHT
• 00818345024007: PADDLE SPREADER, 17MM
• 00818345023994: PADDLE SPREADER, 16MM
• 00818345023987: PADDLE SPREADER, 15MM
• 00818345023970: PADDLE SPREADER, 14MM
• 00818345023963: PADDLE SPREADER, 13MM
• 00818345023956: PADDLE SPREADER, 12MM
• 00818345023949: PADDLE SPREADER, 11MM
• 00818345023932: PADDLE SPREADER, 10MM
• 00818345023925: PADDLE SPREADER, 9MM
• 00818345023918: PADDLE SPREADER, 8MM
• 00818345023901: PADDLE SPREADER, 7MM
• 00818345023895: PADDLE SPREADER, 6MM
• 00818345024113: Paddle Shaver, 16mm
• 00818345024106: Paddle Shaver, 15mm
• 00818345024090: Paddle Shaver, 14mm
• 00818345024083: Paddle Shaver, 13mm
• 00818345024076: Paddle Shaver, 12mm
• 00818345024069: Paddle Shaver, 11mm