KASILOF Cervical Plate System

GUDID B644KCP151100

KASILOF CERVICAL PLATE, 5 LEVEL, 110mm

KAHTNU SURGICAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B644KCP151100
• NIH Device Record Key: 000f6d69-6813-40d8-be0e-98b478b7d3f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KASILOF Cervical Plate System
• Version Model Number: KCP1-5110
• Company DUNS: 081208474
• Company Name: KAHTNU SURGICAL
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B644KCP151100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203154

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

[B644KCP151100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [KASILOF Cervical Plate System]

• B644KCP151100: KASILOF CERVICAL PLATE, 5 LEVEL, 110mm
• B644KCP151050: KASILOF CERVICAL PLATE, 5 LEVEL, 105mm
• B644KCP151000: KASILOF CERVICAL PLATE, 5 LEVEL, 100mm
• B644KCP150950: KASILOF CERVICAL PLATE, 5 LEVEL, 95mm
• B644KCP150900: KASILOF CERVICAL PLATE, 5 LEVEL, 90mm
• B644KCP14900: KASILOF CERVICAL PLATE, 4 LEVEL, 90mm
• B644KCP14870: KASILOF CERVICAL PLATE, 4 LEVEL, 847mm
• B644KCP14840: KASILOF CERVICAL PLATE, 4 LEVEL, 84mm
• B644KCP14810: KASILOF CERVICAL PLATE, 4 LEVEL, 81mm
• B644KCP14780: KASILOF CERVICAL PLATE, 4 LEVEL, 78mm