Cannulated Screw System +

FDA UDI

Class II (US FDA UDI)

by Tyber Medical

Identity

Trade Name: Cannulated Screw System + FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: 4.5MM TI CANN SCREW + ST - 48MM FDA UDI
Model / Reference: 04.353.548 FDA UDI
Description: 4.5MM TI CANN SCREW + ST - 48MM FDA UDI

Identifiers

Catalog Number: 04.353.548 FDA UDI
Primary DI / UDI-DI: 00810040635229 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

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Cannulated Screw System + by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · 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: Tyber Medical

Sources (1)

FDA UDI 648cd5a3-1d16-4bd6-9951-0594a6c5778d 35 fields · synced May 31, 2026