Apelo® / Apelo® MIS 1106-03-8555

GUDID M68111060385550

8.5mm x 55mm Reduction Mono Screw

ATLAS SPINE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M68111060385550
• NIH Device Record Key: 24617b92-da92-44f4-b433-a43cfc0b183f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apelo® / Apelo® MIS
• Version Model Number: 1106-03-8555
• Catalog Number: 1106-03-8555
• Company DUNS: 140801007
• Company Name: ATLAS SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com
• Phone: (561) 741-1108
• Email: sales@atlasspine.com

Device Dimensions

• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68111060385550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072426

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

[M68111060385550]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-08-26
• Device Publish Date: 2014-09-24

On-Brand Devices [Apelo® / Apelo® MIS]

• M68120108000000: Fixed Rod Inserter
• M68120103200000: Dual Tab Breaker
• M68120103100000: Single Tab Breaker
• M68120100800000: MIS Rod Inserter
• M68120100700000: Cannulated Head Removal Tool
• M68120063200000: Tab Removal Tool
• M68120060700000: Head Removal Tool
• M68120100500000: Cannulated Head Applicator
• M68120066800000: Kerrison Rod Holder
• M68120065100000: Curved Rod Holder
• M68120062800000: Rod Holder
• M68120062700000: Power Rod Gripper
• M68120060500000: Head Applicator
• M68120100600000: Cannulated Head Grooming Tool
• M68120060600000: Head Grooming Tool
• M68169102307500: 7.5mm Cannulated Screw Kit
• M68169102105500: 5.5mm Cannulated Screw Kit
• M68169102004500: 4.5mm Cannulated Screw Kit
• M68169101900000: MIS Extended Head Kit
• M68169101800000: MIS Head Kit
• M68169063306500: 6.5mm Reduction Mono Screw Kit
• M68160060900000: 5.5mm Reduction Head Kit
• M68160060300000: 7.5mm Screw Kit
• M68160060100000: 5.5mm Screw Kit
• M68120064000000: Modular Screwdriver Sleeve
• M68120063300000: T-Handle
• M68111100900090: 9mm MIS Extended Head
• M68111100900050: 5mm MIS Extended Head
• M68111100385550: 8.5mm x 55mm Cannulated Reduction Mono Screw
• M68111100365600: 6.5mm x 60mm Cannulated Reduction Mono Screw
• M68111100365550: 6.5mm x 55mm Cannulated Reduction Mono Screw
• M68111100365500: 6.5mm x 50mm Cannulated Reduction Mono Screw
• M68111100365450: 6.5mm x 45mm Cannulated Reduction Mono Screw
• M68111100365400: 6.5mm x 40mm Cannulated Reduction Mono Screw
• M68111100365350: 6.5mm x 35mm Cannulated Reduction Mono Screw
• M68111100365300: 6.5mm x 30mm Cannulated Reduction Mono Screw
• M68111100355250: 5.5mm x 25mm Cannulated Reduction Mono Screw
• M68111100345450: 4.5mm x 45mm Cannulated Reduction Mono Screw
• M68111100285500: 8.5mm x 50mm Cannulated Mono Screw
• M68111100285300: 8.5mm x 30mm Cannulated Mono Screw
• M68111100275600: 7.5mm x 60mm Cannulated Mono Screw
• M68111100275450: 7.5mm x 45mm Cannulated Mono Screw
• M68111100275350: 7.5mm x 35mm Cannulated Mono Screw
• M68111100265250: 6.5mm x 25mm Cannulated Mono Screw
• M68111100255450: 5.5mm x 45mm Cannulated Mono Screw
• M68111100255400: 5.5mm x 40mm Cannulated Mono Screw
• M68111100185550: 8.5mm x 55mm Cannulated Modular Screw
• M68111100185350: 8.5mm x 35mm Cannulated Modular Screw
• M68111100185300: 8.5mm x 30mm Cannulated Modular Screw
• M68111100175350: 7.5mm x 35mm Cannulated Modular Screw