KASILOF Cervical Plate System

GUDID B644KCP14400160

KASILOF FA Self-Tapping Screw 4.0 x 16mm

AXIS360 SURGICAL, INCOPORATED

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B644KCP14400160
• NIH Device Record Key: c6c925c1-60ea-46e7-b6cd-e0a2dafa0fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KASILOF Cervical Plate System
• Version Model Number: KCP1-440-016
• Company DUNS: 081208474
• Company Name: AXIS360 SURGICAL, INCOPORATED
• 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	B644KCP14400160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173867

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

[B644KCP14400160]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-17
• Device Publish Date: 2018-09-01

On-Brand Devices [KASILOF Cervical Plate System]

• B644KCP15451180: KASILOF VA Self-Drilling Screw 4.5 x 18mm
• B644KCP15451160: KASILOF VA Self-Drilling Screw 4.5 x 16mm
• B644KCP15451140: KASILOF VA Self-Drilling Screw 4.5 x 14mm
• B644KCP15451120: KASILOF VA Self-Drilling Screw 4.5 x 12mm
• B644KCP15451100: KASILOF VA Self-Drilling Screw 4.5 x 10mm
• B644KCP15401180: KASILOF VA Self-Drilling Screw 4.0 x 18mm
• B644KCP15401160: KASILOF VA Self-Drilling Screw 4.0 x 16mm
• B644KCP15401140: KASILOF VA Self-Drilling Screw 4.0 x 14mm
• B644KCP15401120: KASILOF VA Self-Drilling Screw 4.0 x 12mm
• B644KCP15401100: KASILOF VA Self-Drilling Screw 4.0 x 10mm
• B644KCP15400180: KASILOF VA Self-Tapping Screw 4.0 x 18mm
• B644KCP15400160: KASILOF VA Self-Tapping Screw 4.0 x 16mm
• B644KCP15400140: KASILOF VA Self-Tapping Screw 4.0 x 14mm
• B644KCP15400120: KASILOF VA Self-Tapping Screw 4.0 x 12mm
• B644KCP15400100: KASILOF VA Self-Tapping Screw 4.0 x 10mm
• B644KCP14400180: KASILOF FA Self-Tapping Screw 4.0 x 18mm
• B644KCP14400160: KASILOF FA Self-Tapping Screw 4.0 x 16mm
• B644KCP14400140: KASILOF FA Self-Tapping Screw 4.0 x 14mm
• B644KCP14400120: KASILOF FA Self-Tapping Screw 4.0 x 12mm
• B644KCP14400100: KASILOF FA Self-Tapping Screw 4.0 x 10mm
• B644KCP13780: KASILOF Cervical Plate 3 Level 78mm
• B644KCP13750: KASILOF Cervical Plate 3 Level 75mm
• B644KCP13720: KASILOF Cervical Plate 3 Level 72mm
• B644KCP13690: KASILOF Cervical Plate 3 Level 69mm
• B644KCP13660: KASILOF Cervical Plate 3 Level 66mm
• B644KCP13630: KASILOF Cervical Plate 3 Level 63mm
• B644KCP13600: KASILOF Cervical Plate 3 Level 60mm
• B644KCP13570: KASILOF Cervical Plate 3 Level 57mm
• B644KCP13540: KASILOF Cervical Plate 3 Level 54mm
• B644KCP12550: KASILOF Cervical Plate 2 Level 55mm
• B644KCP12530: KASILOF Cervical Plate 2 Level 53mm
• B644KCP12510: KASILOF Cervical Plate 2 Level 51mm
• B644KCP12490: KASILOF Cervical Plate 2 Level 49mm
• B644KCP12470: KASILOF Cervical Plate 2 Level 47mm
• B644KCP12450: KASILOF Cervical Plate 2 Level 45mm
• B644KCP12430: KASILOF Cervical Plate 2 Level 43mm
• B644KCP12410: KASILOF Cervical Plate 2 Level 41mm
• B644KCP12390: KASILOF Cervical Plate 2 Level 39mm
• B644KCP12370: KASILOF Cervical Plate 2 Level 37mm
• B644KCP12350: KASILOF Cervical Plate 2 Level 35mm
• B644KCP11350: KASILOF Cervical Plate 1 Level 35mm
• B644KCP11330: KASILOF Cervical Plate 1 Level 33mm
• B644KCP11310: KASILOF Cervical Plate 1 Level 31mm
• B644KCP11290: KASILOF Cervical Plate 1 Level 29mm
• B644KCP11270: KASILOF Cervical Plate 1 Level 27mm
• B644KCP11250: KASILOF Cervical Plate 1 Level 25mm
• B644KCP11230: KASILOF Cervical Plate 1 Level 23mm
• B644KCP11210: KASILOF Cervical Plate 1 Level 21mm
• B644KCP11190: KASILOF Cervical Plate 1 Level 19mm