Fassier-Duval Telescopic Im System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref FD-LCP-180Model LOCKING PIN

by Orthopediatrics Canada ULC

Identity

Trade Name: The Fassier-Duval Telescopic IM System EUDAMED
FASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: LOCKING PIN Ø1.8mm x 150mm FDA UDI
Model / Reference: FD-LCP-180 EUDAMEDFDA UDI
LOCKING PIN EUDAMED
Description: LOCKING PIN Ø1.8mm x 150mm FDA UDI

Identifiers

Catalog Number: FD-LCP-180 FDA UDI
Primary DI / UDI-DI: 07540194012128 EUDAMEDFDA UDI
Basic UDI-DI: 7540194FD-LPRA EUDAMED
510(k) Number: K020885 FDA UDI
K041393 FDA UDI
FDA Product Code: HSB FDA UDI
EMDN Code: P09120399 BONE FIXATION WIRES - OTHER 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: Outer Diameter — 1.8 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 5d41ccf8-0be3-4102-9e0a-9d701ac939d2 38 fields · synced Oct 5, 2026
EUDAMED f05a3e8a-5704-4a55-826d-b2cc97d5760e 61 fields · synced Oct 5, 2026