EpiFIX

Basic Information

• Brand Name: EpiFIX
• Primary DI: B562XKEFC0422SSUS0
• Version / Model: XK-EFC0422SS-US
• Catalog Number: XK-EFC0422SS
• Company Name: Wishbone Medical, Inc.
• Labeler DUNS: 062355158
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-15
• Public Version: 5
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 13d596e7-48fb-4e8e-bba2-9ab8d5692dab
• Distribution End Date: 2021-12-31

Device Description

Express Kit, Curved 4-Hole x 22mm EpiFIX Plate, Instruments and Solid Screws, SS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44896	Growth-correction orthopaedic fixation plate kit	A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B562XKEFC0422SSUS0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K182704	000