Foundation Surgical Instruments

Basic Information

• Brand Name: Foundation Surgical Instruments
• Primary DI: 00810141040922
• Version / Model: FSN-020000
• Catalog Number: FSN-020000
• Company Name: FOUNDATION SURGICAL GROUP INC
• Labeler DUNS: 119029419
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-05
• Public Version: 1
• Public Version Date: 2026-03-13
• Public Version Status: New
• Public Device Record Key: 1de96621-4a64-4f69-8ee8-45d0df0b1980

Device Description

Staple Driver

Device Characteristics

• Single Use: No
• 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: 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47807	Surgical implant/trial-implant/sizer holder, reusable	A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810141040922	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K241487	000