GAITWAY

Basic Information

• Brand Name: GAITWAY
• Primary DI: 00840420170637
• Version / Model: 30-100-02
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 807201207
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-15
• Public Version: 5
• Public Version Date: 2025-02-06
• Public Version Status: Update
• Public Device Record Key: 93962007-439f-41a2-a2e0-129edfb5e366
• Distribution End Date: 2016-03-14

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: 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: 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
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40352	Subtalar implant, non-bioabsorbable	A device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities; it is not intended for arthrodesis/joint fusion. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840420170637	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122738	000