nuMIS Lumbar Plating System 27198

GUDID 00841193120478

nuMIS™ Drill Driver

Cutting Edge Spine, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841193120478
• NIH Device Record Key: 14b80581-f7a4-4b52-b2e6-e05454b68681
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nuMIS Lumbar Plating System
• Version Model Number: 27198
• Catalog Number: 27198
• Company DUNS: 069472647
• Company Name: Cutting Edge Spine, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: +1(704)243-0892
• Email: B.Roof@cuttingedgespine.com

Device Dimensions

• Length: 6 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841193120478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051044

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841193120478]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

On-Brand Devices [nuMIS Lumbar Plating System]

• 00841193120478: nuMIS™ Drill Driver
• 00841193120461: nuMIS™ Nut Driver
• 00841193103099: nuMIS™ Long Hex Driver
• 00841193102498: 6.75 x 30 mm Long Threaded, Ti Bolt
• 00841193102481: 7.25 x 30 mm Long Threaded, Ti Bolt
• 00841193102474: 7.75 x 30 mm Long Threaded, Ti Bolt
• 00841193102467: 8.5 x 50mm Long Threaded, Ti Bolt
• 00841193102450: 8.5 x 45mm Long Threaded, Ti Bolt
• 00841193102443: 8.5 x 40 mm Long Threaded, Ti Bolt
• 00841193102436: 8.5 x 35 mm Long Threaded, Ti Bolt
• 00841193102429: 8.5 x 30 mm Long Threaded, Ti Bolt
• 00841193102412: 5.75 x 35 mm Long Threaded, Ti Bolt
• 00841193101637: 5.75 x 50 mm Long Threaded, Ti Bolt
• 00841193101620: 5.75 x 45 mm Long Threaded, Ti Bolt
• 00841193101613: 5.75 x 40 mm Long Threaded, Ti Bolt
• 00841193101606: 7.75 x 50 mm Long Threaded, Ti Bolt
• 00841193101590: 7.75 x 45 mm Long Threaded, Ti Bolt
• 00841193101583: 7.75 x 40 mm Long Threaded, Ti Bolt
• 00841193101576: 7.75 x 35 mm Long Threaded, Ti Bolt
• 00841193101354: 7.25 x 50 mm Long Threaded, Ti Bolt
• 00841193101347: 7.25 x 45 mm Long Threaded, Ti Bolt
• 00841193101330: 7.25 x 40 mm Long Threaded, Ti Bolt
• 00841193101323: 7.25 x 35 mm Long Threaded, Ti Bolt
• 00841193101316: 180 mm Ti Full Slot Plate
• 00841193101309: 160 mm Ti Full Slot Plate
• 00841193101293: 140 mm Ti Full Slot Plate
• 00841193101286: 130 mm Ti Full Slot Plate
• 00841193101279: 120 mm Ti Full Slot Plate
• 00841193101262: 110 mm Ti Full Slot Plate
• 00841193101255: 100 mm Ti Full Slot Plate
• 00841193101248: 90 mm Ti Full Slot Plate
• 00841193101231: 80 mm Ti Full Slot Plate
• 00841193101224: 70 mm Ti Full Slot Plate
• 00841193101217: 65 mm Ti Full Slot Plate
• 00841193101200: 60 mm Ti Full Slot Plate
• 00841193101194: 50 mm Ti Full Slot Plate
• 00841193101187: 40 mm Ti Full Slot Plate
• 00841193101170: Ti Nut
• 00841193101163: Ti Washer
• 00841193101156: 6.75 x 50 mm Long Threaded, Ti Bolt
• 00841193101149: 6.75 x 45 mm Long Threaded, Ti Bolt
• 00841193101132: 6.75 x 40 mm Long Threaded, Ti Bolt
• 00841193101125: 6.75 x 35 mm Long Threaded, Ti Bolt