RTS Lesser MTP Implant

Basic Information

• Brand Name: RTS Lesser MTP Implant
• Primary DI: 00817906024302
• Version / Model: M40 SE030
• Company Name: IN2BONES USA, LLC
• Labeler DUNS: 079700711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-08
• Public Version: 3
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: da32a555-07ff-4015-b4d1-b27c45291487

Device Description

Size 3

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: No
• 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
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	888.3720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33700	Total metatarsophalangeal joint prosthesis, one-piece	An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817906024302	GS1

Premarket Submissions

Submission Number	Supplement Number
K173491	000