BioWick X

GUDID M543CM6255

BioWick X 5.5mm Pre-Loaded Implant

CAYENNE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: M543CM6255
• NIH Device Record Key: 492e5000-483b-4ef3-a3ca-d69da2213cb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioWick X
• Version Model Number: CM-6255
• Company DUNS: 606719685
• Company Name: CAYENNE MEDICAL, INC.
• 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: true
• 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	M543CM6255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172186

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-10-21
• Device Publish Date: 2018-01-31

On-Brand Devices [BioWick X]

• 00887868269813: BioWick X 6.5mm Pre-Loaded Implant
• 00887868269790: BioWick X 5.5mm Pre-Loaded Implant
• M543CM6265: BioWick X 6.5mm Pre-Loaded Implant
• M543CM6255: BioWick X 5.5mm Pre-Loaded Implant