Asfora Anterior Cervical Plate System

GUDID 111106122

1 Level, 22mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

MEDICAL DESIGNS LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 111106122
• NIH Device Record Key: c4fa522f-9013-4ca4-a169-09b6b8b2e333
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asfora Anterior Cervical Plate System
• Version Model Number: 11-1106-FD1-22
• 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: 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

Customer Support Contacts

• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	111106122 [Direct Marking]
HIBCC	M364111106FD1220 [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

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

[111106122]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• 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