Wichita 6647-2-012

GUDID 07613327045116

Fusion Nail

Howmedica Osteonics Corp.

Arthrodesis nail, sterile Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length

• Primary Device ID: 07613327045116
• NIH Device Record Key: 9fd85743-2cc6-4807-b6df-921ac1c8fde4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wichita
• Version Model Number: 6647-2-012
• Catalog Number: 6647-2-012
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327045116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952923

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Wichita]

• 07613327050189: Self Tapping Screw
• 07613327050172: Self Tapping Screw
• 07613327050165: Self Tapping Screw
• 07613327050158: Self Tapping Screw
• 07613327050141: Self Tapping Screw
• 07613327050134: Self Tapping Screw
• 07613327050127: Self Tapping Screw
• 07613327050110: Self Tapping Screw
• 07613327050103: Compression Screw
• 07613327045116: Fusion Nail
• 07613327045093: Femoral Component