Spinal Jaxx Interbody Fusion Device 100001-641

GUDID 00818956021143

Spinal Jaxx Implant, 13Hx10Wx27L mm

NEUROPRO SPINAL JAXX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00818956021143
• NIH Device Record Key: 21529e88-8ad1-44c3-9304-a4c340164a59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinal Jaxx Interbody Fusion Device
• Version Model Number: 100001-641
• Catalog Number: 100001-641
• Company DUNS: 080554344
• Company Name: NEUROPRO SPINAL JAXX INC.
• 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: 209-545-5111
• Email: contact@neuroprotech.com

Device Dimensions

• Length: 27 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818956021143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152501

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [Spinal Jaxx Interbody Fusion Device]

• 00818956020870: Endplate Rasp
• 00818956020863: T-Handle
• 00818956020856: 14 mm Rotating Scraper
• 00818956020849: 13 mm Rotating Scraper
• 00818956020832: 12 mm Rotating Scraper
• 00818956020825: 11 mm Rotating Scraper
• 00818956020818: 10 mm Rotating Scraper
• 00818956020801: 9 mm Rotating Scraper
• 00818956020795: 8 mm Rotating Scraper
• 00818956020788: 7 mm Rotating Scraper
• 00818956020771: 6 mm Rotating Scraper
• 00818956020764: 5 mm Rotating Scraper
• 00818956020757: Spinal Jaxx Bone Prep Case
• 00818956020740: Rescue Hook
• 00818956020733: Redocking Tool
• 00818956020726: 33 mm Implant Height Indicator
• 00818956020719: 29 mm Implant Height Indicator
• 00818956020702: 25 mm Implant Height Indicator
• 00818956020696: 21 mm Implant Height Indicator
• 00818956020689: Implant Inserter
• 00818956020672: Screw Driver
• 00818956020665: Expandable Sizer
• 00818956020658: Sifter
• 00818956020641: Initial Plunger
• 00818956020634: Secondary Plunger
• 00818956020627: Docking Rod
• 00818956020610: Flexible Plunger
• 00818956020603: Spatula
• 00818956020597: External Graft Delivery
• 00818956020580: Implant Graft Delivery, 29 mm & 33 mm
• 00818956020573: Implant Graft Delivery, 21 mm & 25 mm
• 00818956020566: Spinal Jaxx Instrument Case
• 00818956020559: Spinal Jaxx OsteoSync Implant, 13 H x 12 W x 33 L mm
• 00818956020542: Spinal Jaxx OsteoSync Implant, 13 H x 10 W x 33 L mm
• 00818956020535: Spinal Jaxx OsteoSync Implant, 13 H x 12 W x 29 L mm
• 00818956020528: Spinal Jaxx OsteoSync Implant, 13 H x 10 W x 29 L mm
• 00818956020511: Spinal Jaxx OsteoSync Implant, 13 H x 12 W x 25 L mm
• 00818956020504: Spinal Jaxx OsteoSync Implant, 13 H x 10 W x 25 L mm
• 00818956020498: Spinal Jaxx OsteoSync Implant, 13 H x 12 W x 21 L mm
• 00818956020481: Spinal Jaxx OsteoSync Implant, 13 H x 10 W x 21 L mm
• 00818956020474: Spinal Jaxx OsteoSync Implant, 11 H x 12 W x 33 L mm
• 00818956020467: Spinal Jaxx OsteoSync Implant, 11 H x 10 W x 33 L mm
• 00818956020450: Spinal Jaxx OsteoSync Implant, 11 H x 12 W x 29 L mm
• 00818956020443: Spinal Jaxx OsteoSync Implant, 11 H x 10 W x 29 L mm
• 00818956020436: Spinal Jaxx OsteoSync Implant, 11 H x 12 W x 25 L mm
• 00818956020429: Spinal Jaxx OsteoSync Implant, 11 H x 10 W x 25 L mm
• 00818956020412: Spinal Jaxx OsteoSync Implant, 11 H x 12 W x 21 L mm
• 00818956020405: Spinal Jaxx OsteoSync Implant, 11 H x 10 W x 21 L mm
• 00818956020399: Spinal Jaxx OsteoSync Implant, 9 H x 12 W x 33 L mm
• 00818956020382: Spinal Jaxx OsteoSync Implant, 9 H x 10 W x 33 L mm