The Better Bunion

Basic Information

• Brand Name: The Better Bunion
• Primary DI: G2710120320210
• Version / Model: Lapidus
• Company Name: Mios Marketing, LLC
• Labeler DUNS: 118723037
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-19
• Public Version: 1
• Public Version Date: 2022-08-29
• Public Version Status: New
• Public Device Record Key: 7cf0bb72-efdf-41b5-a885-2a8d5f830cf8
• Distribution End Date: 2099-12-31

Device Description

Standard Lapidus Guide, Left 32mm x 21mm

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63198	Orthopaedic implant aiming/guiding block, single-use	A sterile surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G2710120320210	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K220717	000

Device Sizes

Type	Value	Unit	Text
Length	32	Millimeter
Depth	21	Millimeter