RTS Lesser MTP Implant

GUDID 00817906024296

Size 2

IN2BONES USA, LLC

Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece

• Primary Device ID: 00817906024296
• NIH Device Record Key: de1252fd-e75b-4a7c-aab9-f5db773da987
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RTS Lesser MTP Implant
• Version Model Number: M40 SE020
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817906024296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173491

FDA Product Code

• KWH: Prosthesis, Toe, Constrained, Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-08

On-Brand Devices [RTS Lesser MTP Implant]

• 00817906024319: Instruments
• 00817906024302: Size 3
• 00817906024296: Size 2
• 00817906024289: Size 1