Procedure Kit, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti

GUDID B562PKEFC0422TUS0

WISHBONE MEDICAL, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: B562PKEFC0422TUS0
• NIH Device Record Key: 95dca933-3b48-4451-9acf-9a499d53bb66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Kit, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti
• Version Model Number: PK-EFC0422T-US
• 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	B562PKEFC0422TUS0 [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, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti ]

• B562PKEFC0422TUS0: PK-EFC0422T-US
• B562PKEFC0422T0: PK-EFC0422T