Fassier-Duval Telescopic Im System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref PEG-20-028Model PEG IMPLANT

by Orthopediatrics Canada ULC

Identity

Trade Name: The Simple Locking Intra Medullary System EUDAMED
FASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: PEG Ø2.0mm x 28mm FDA UDI
Model / Reference: PEG-20-028 EUDAMEDFDA UDI
PEG IMPLANT EUDAMED
Description: PEG Ø2.0mm x 28mm FDA UDI

Identifiers

Catalog Number: PEG-20-028 FDA UDI
Primary DI / UDI-DI: 07540194012258 EUDAMEDFDA UDI
Basic UDI-DI: 7540194SLM-PEGN4Q EUDAMED
510(k) Number: K020885 FDA UDI
K041393 FDA UDI
FDA Product Code: HSB FDA UDI
EMDN Code: P09120601 CORTICAL SCREWS EUDAMED
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Market of Registration: Sweden EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Dimensions & Sizes

Size: Length — 28 Millimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Fassier-Duval Telescopic Im System by Orthopediatrics Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Canada ULC

Sources (2)

FDA UDI 218ff3bc-1277-4926-ac24-e9c1826ea3cc 38 fields · synced Jun 18, 2026
EUDAMED 2e937ee2-cf90-44c6-9770-7d82877ba269 61 fields · synced Jun 18, 2026