WishFIX

Basic Information

• Brand Name: WishFIX
• Primary DI: B562TEFSS2008US0
• Version / Model: TEFSS20-08-US
• Catalog Number: TEFSS20
• Company Name: Wishbone Medical, Inc.
• Labeler DUNS: 062355158
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-22
• Public Version: 3
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 75aaa6c7-09b3-49fb-a85a-3b8f81060823

Device Description

4.5mm x 20mm WishFIX Solid Screw, Ti, T20 Head

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B562TEFSS2008US0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K182704	000