TiWAVE L Lumbar Cage System

GUDID B07323LCN20170

Porous Titanium Cage, 20x17mm, 0 Degree, Non-Taper, Straight

Kalitec Direct LLC

Metallic spinal interbody fusion cage

• Primary Device ID: B07323LCN20170
• NIH Device Record Key: 7495ada5-4de4-459d-8934-8bd0a8e4585b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiWAVE L Lumbar Cage System
• Version Model Number: 23-LCN-2017
• Company DUNS: 041956211
• Company Name: Kalitec Direct 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07323LCN20170 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-01-29

On-Brand Devices [TiWAVE L Lumbar Cage System]

• BO7323K0104000: Caddie, Trials
• B07323LTX30170: Trial, 30 x 17mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30160: Trial, 30 x 16mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30150: Trial, 30 x 15mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30140: Trial, 30 x 14mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30130: Trial, 30 x 13mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30120: Trial, 30 x 12mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30110: Trial, 30 x 11mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30100: Trial, 30 x 10mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30090: Trial, 30 x 9mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30080: Trial, 30 x 8mm, 15 Degree, Extra Tapered, Straight
• B07323LTX30070: Trial, 30 x 7mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28170: Trial, 28 x 17mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28160: Trial, 28 x 16mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28150: Trial, 28 x 15mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28140: Trial, 28 x 14mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28130: Trial, 28 x 13mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28120: Trial, 28 x 12mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28110: Trial, 28 x 11mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28100: Trial, 28 x 10mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28090: Trial, 28 x 9mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28080: Trial, 28 x 8mm, 15 Degree, Extra Tapered, Straight
• B07323LTX28070: Trial, 28 x 7mm, 15 Degree, Extra Tapered, Straight
• B07323LTX25170: Trial, 25 x 17mm, 15 Degree, Extra Taper, Straight
• B07323LTX25160: Trial, 25 x 16mm, 15 Degree, Extra Taper, Straight
• B07323LTX25150: Trial, 25 x 15mm, 15 Degree, Extra Taper, Straight
• B07323LTX25140: Trial, 25 x 14mm, 15 Degree, Extra Taper, Straight
• B07323LTX25130: Trial, 25 x 13mm, 15 Degree, Extra Taper, Straight
• B07323LTX25120: Trial, 25 x 12mm, 15 Degree, Extra Taper, Straight
• B07323LTX25110: Trial, 25 x 11mm, 15 Degree, Extra Taper, Straight
• B07323LTX25100: Trial, 25 x 10mm, 15 Degree, Extra Taper, Straight
• B07323LTX25090: Trial, 25 x 9mm, 15 Degree, Extra Taper, Straight
• B07323LTX25080: Trial, 25 x 8mm, 15 Degree, Extra Taper, Straight
• B07323LTX25070: Trial, 25 x 7mm, 15 Degree, Extra Taper, Straight
• B07323LTX22170: Trial, 22 x 17mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22160: Trial, 22 x 16mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22150: Trial, 22 x 15mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22140: Trial, 22 x 14mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22130: Trial, 22 x 13mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22120: Trial, 22 x 12mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22110: Trial, 22 x 11mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22100: Trial, 22 x 10mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22090: Trial, 22 x 9mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22080: Trial, 22 x 8mm, 15 Degree,Extra Tapered, Straight
• B07323LTX22070: Trial, 22 x 7mm, 15 Degree,Extra Tapered, Straight
• B07323LTX20170: Trial, 20 x 17mm, 15 Degree, Extra Tapered, Straight
• B07323LTX20160: Trial, 20 x 16mm, 15 Degree, Extra Tapered, Straight
• B07323LTX20150: Trial, 20 x 15mm, 15 Degree, Extra Tapered, Straight
• B07323LTX20140: Trial, 20 x 14mm, 15 Degree, Extra Tapered, Straight
• B07323LTX20130: Trial, 20 x 13mm, 15 Degree, Extra Tapered, Straight