Elos

FDA UDI

Class II (US FDA UDI)

by Intrauma Spa

Identity

Trade Name: ELOS FDA UDI
Generic Name: Femur intramedullary nail FDA UDI
Device Name: Long Nail, LEFT FDA UDI
Model / Reference: 200.3201 FDA UDI
Description: Long Nail, LEFT FDA UDI

Identifiers

Catalog Number: 200.3201 FDA UDI
Primary DI / UDI-DI: 08056693000706 FDA UDI
510(k) Number: K201147 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Femur intramedullary nail FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 10 Millimeter FDA UDI
Length — 300 Millimeter FDA UDI

Category: Femur intramedullary nail

Elos by Intrauma Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femur intramedullary nail.

GAMMA — Stryker Corp. · Class II
A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
T2 ALPHA — Stryker Corp. · Class II
PRECICE® Bone Transport System — NuVasive Specialized Orthopedics, Inc. · Class II
T2 — Stryker Corp. · Class II
130° Ga-mma Nail — Auxein Medical Private Limited · Class II
ARIX Femur Nail System — Jeil Medical Corporation · Class II
INTERTAN — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K201147 also covers:

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: Intrauma Spa

Sources (1)

FDA UDI 75c7a859-081d-4f28-a11d-f1fc73c031f4 36 fields · synced May 30, 2026