3.5mm x 8mm Ti Locking Screw

GUDID B562TLK350080

WISHBONE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: B562TLK350080
• NIH Device Record Key: b4d55dc5-e8c0-4e89-826b-08724caeea34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm x 8mm Ti Locking Screw
• Version Model Number: TLK35008
• Company DUNS: 062355158
• Company Name: WISHBONE 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: true
• 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	B562TLK350080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180736

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-25
• Device Publish Date: 2019-11-15

On-Brand Devices [3.5mm x 8mm Ti Locking Screw ]

• B562TLK350080: TLK35008
• B562TLK35008US0: TLK35008-US