Hallu-Lock

FDA UDI

Class II (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: HALLU-LOCK FDA UDI
Generic Name: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Device Name: The Hallu-Lock plate system is a low profile titanium plate dedicated to the first metatarsophalangeal arthrodesis. This system includes Hallu-Lock C plates, Hallu-Lock S plates, screws, and instruments. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint. FDA UDI
Model / Reference: HALULCKIMP FDA UDI
Description: The Hallu-Lock plate system is a low profile titanium plate dedicated to the first metatarsophalangeal arthrodesis. This system includes Hallu-Lock C plates, Hallu-Lock S plates, screws, and instruments. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint. FDA UDI

Identifiers

Catalog Number: HALULCKIMP FDA UDI
Primary DI / UDI-DI: 10381780064473 FDA UDI
510(k) Number: K022599 FDA UDI
K083154 FDA UDI
FDA Product Code: HWC FDA UDI
HTY FDA UDI
HRS FDA UDI
GMDN Term: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile 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-Lock by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K022599 also covers:

K083154 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 3ef71274-e7da-4b94-8b7b-24e9c161ab08 38 fields · synced Jun 8, 2026