Ipp-On

FDA UDI

Class II (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: IPP-ON FDA UDI
Generic Name: General internal orthopaedic fixation system implantation kit FDA UDI
Device Name: The IPP-ON set includes instruments to be used as a guide for Interphalangeal implants. The interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe. FDA UDI
Model / Reference: IPPONINSTP FDA UDI
Description: The IPP-ON set includes instruments to be used as a guide for Interphalangeal implants. The interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe. FDA UDI

Identifiers

Catalog Number: IPPONINSTP FDA UDI
Primary DI / UDI-DI: 10381780125877 FDA UDI
510(k) Number: K103623 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Ipp-On by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K103623 also covers:

IPP-ON — Newdeal Sas
IPP-ON — Newdeal Sas

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Newdeal Sas

Sources (1)

FDA UDI a35f8d66-2177-4c0e-b0df-74219b7b1f3a 38 fields · synced May 30, 2026