V3™ Segmental Plating System 1121-01-0015

GUDID M68111210100150

15mm Plate Assembly

ATLAS SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: M68111210100150
• NIH Device Record Key: 1acb2248-6221-41f6-835e-2a9448a8993b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V3™ Segmental Plating System
• Version Model Number: 1121-01-0015
• Catalog Number: 1121-01-0015
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Dimensions

• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68111210100150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182418

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

[M68111210100150]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-01
• Device Publish Date: 2020-09-23

On-Brand Devices [V3™ Segmental Plating System]

• M68111210400160: 16mm Rescue Screw
• M68111210400140: 14mm Rescue Screw
• M68111210400120: 12mm Rescue Screw
• M68111210300160: 16mm Fixed Screw
• M68111210300140: 14mm Fixed Screw
• M68111210300120: 12mm Fixed Screw
• M68111210200160: 16mm Variable Screw
• M68111210200140: 14mm Variable Screw
• M68111210200120: 12mm Variable Screw
• M68111210100170: 17mm Plate Assembly
• M68111210100150: 15mm Plate Assembly
• M68111210100130: 13mm Plate Assembly
• M68111210100110: 11mm Plate Assembly
• M68111210100090: 9mm Plate Assembly