Hallu-Fix

FDA UDI

Class II (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: HALLU-FIX FDA UDI
Generic Name: General internal orthopaedic fixation system implantation kit FDA UDI
Device Name: The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments. The Hallu Plates are low profile titanium plates dedicated to first metatarsophalangeal arthrodesis. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint. FDA UDI
Model / Reference: HALUINSTSET FDA UDI
Description: The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments. The Hallu Plates are low profile titanium plates dedicated to first metatarsophalangeal arthrodesis. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint. FDA UDI

Identifiers

Catalog Number: HALUINSTSET FDA UDI
Primary DI / UDI-DI: 10381780064404 FDA UDI
510(k) Number: K021626 FDA UDI
K022599 FDA UDI
K093781 FDA UDI
FDA Product Code: HTY FDA UDI
HRS 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
888.3030 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

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

Cleared under the same submission

K021626 also covers:

K022599 also covers:

K093781 also covers:

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 02e16aba-bece-4414-97a2-7cb2b69c9ac9 38 fields · synced May 31, 2026