Cancellous Screw, Locking, SH

FDA UDI

Class II (US FDA UDI)

by I.T.S. GmbH

Identity

Trade Name: Cancellous Screw, Locking, SH FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Cancellous Screw, Locking, SH, D=4.2mm, L=14mm FDA UDI
Model / Reference: 37422-14-N FDA UDI
Description: Cancellous Screw, Locking, SH, D=4.2mm, L=14mm FDA UDI

Identifiers

Catalog Number: 37422-14-N FDA UDI
Primary DI / UDI-DI: 09120047295458 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Cancellous Screw, Locking, SH by I.T.S. GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

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STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
PANGEA — Stryker Corp. · Class II
ARIX System Bone Screw — Jeil Medical Corporation · Class II

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: I.T.S. GmbH

Sources (1)

FDA UDI e3b8fe82-4424-478a-84bb-c6850668199e 34 fields · synced Jun 8, 2026