Procedure Kit, Stepped 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti

GUDID B562PKEFS0216T0

WISHBONE MEDICAL, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: B562PKEFS0216T0
• NIH Device Record Key: fd86e5e5-4a0f-4eda-85e8-57e2de8faf00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Kit, Stepped 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti
• Version Model Number: PK-EFS0216T
• 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: true
• 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	B562PKEFS0216T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182704

FDA Product Code

• OBT: Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

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: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [Procedure Kit, Stepped 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti]

• B562PKEFS0216TUS0: PK-EFS0216T-US
• B562PKEFS0216T0: PK-EFS0216T