Asfora Anterior Cervical Plate System

GUDID 11110641

Fixed Angle Drill Guide

MEDICAL DESIGNS LLC

Surgical drill guide, reusable

• Primary Device ID: 11110641
• NIH Device Record Key: c1b67d36-011f-4acd-a0ab-84e395fe9bef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asfora Anterior Cervical Plate System
• Version Model Number: 11-1106-FD41
• Company DUNS: 003815548
• Company Name: MEDICAL DESIGNS 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	11110641 [Direct Marking]
HIBCC	M364111106FD410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143688

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[11110641]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-27

On-Brand Devices [Asfora Anterior Cervical Plate System]

• 111106273: Screw Extractor Wedge Lock
• 111106272: Screw Extractor Driver
• 111106271: Screw Extractor Sleeve
• 11110641: Fixed Angle Drill Guide
• 11110629: Variable Angle Drill Guide
• 11110643: Axial Driver Handle
• 11110642: Axial Drill Bit Handle
• 111106494: 4 Level, 94mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106490: 4 Level, 90mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106486: 4 Level, 86mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106482: 4 Level, 82mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106478: 4 Level, 78mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106474: 4 Level, 74mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106375: 3 Level, 75mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106372: 3 Level, 72mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106369: 3 Level, 69mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106366: 3 Level, 66mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106363: 3 Level, 63mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106360: 3 Level, 60mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106357: 3 Level, 57mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106354: 3 Level, 54mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106351: 3 Level, 51mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106250: 2 Level, 50mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106247: 2 Level, 47mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106244: 2 Level, 44mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106241: 2 Level, 41mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106238: 2 Level, 38mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106235: 2 Level, 35mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106232: 2 Level, 32mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106134: 1 Level, 34mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106132: 1 Level, 32mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106130: 1 Level, 30mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106128: 1 Level, 28mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106126: 1 Level, 26mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106124: 1 Level, 24mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• 111106122: 1 Level, 22mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
• M364111106FD1200: 1 Level, 20mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t