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Fassier-Duval Telescopic Im System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref FD-056(SPS)-SSModel NAIL IMPLANT

by Orthopediatrics Canada ULC

Identity

Trade Name
The Fassier-Duval Telescopic IM System EUDAMED
FASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
Generic Name
Arthrodesis intramedullary nail, non-distracting FDA UDI
Device Name
Short Tibial/Humeral Nail Assy Ø5.6mm x 405mm FDA UDI
Model / Reference
FD-056(SPS)-SS EUDAMEDFDA UDI
NAIL IMPLANT EUDAMED
Description
Short Tibial/Humeral Nail Assy Ø5.6mm x 405mm FDA UDI

Identifiers

Catalog Number
FD-056(SPS)-SS FDA UDI
Primary DI / UDI-DI
07540194000477 EUDAMEDFDA UDI
Basic UDI-DI
7540194FD-NAILSM7 EUDAMED
510(k) Number
K020885 FDA UDI
K041393 FDA UDI
FDA Product Code
HSB FDA UDI
EMDN Code
P09120201 INTRAMEDULLARY NAILS EUDAMED
GMDN Term
Arthrodesis intramedullary nail, non-distracting 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

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.6 Millimeter FDA UDI
Length — 405 Millimeter FDA UDI

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

Cleared under the same submission

K020885 also covers:

K041393 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Canada ULC

Sources (2)

  • FDA UDI daa620c1-6fd6-41b0-9bdb-5de318b08609 38 fields · synced Oct 7, 2026
  • EUDAMED 99d7ed1c-edf0-4a10-9fb2-1b5a2b5b6b79 61 fields · synced Aug 3, 2026