Eba2

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: EBA2 FDA UDI
Generic Name: Femur intramedullary nail FDA UDI
Device Name: Kit composed of: - Right Nail ø13mm L420mm (1 pc); - Guide wire (1 pc). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI
Model / Reference: Long nail ø13mm L420mm, right FDA UDI
Description: Kit composed of: - Right Nail ø13mm L420mm (1 pc); - Guide wire (1 pc). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI

Identifiers

Catalog Number: EBA-661342 FDA UDI
Primary DI / UDI-DI: 08032909625413 FDA UDI
510(k) Number: K131005 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Length — 420 Millimeter FDA UDI
Outer Diameter — 13 Millimeter FDA UDI

Category: Femur intramedullary nail

Eba2 by Citieffe — 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

K131005 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: Citieffe

Sources (1)

FDA UDI 515326a9-bd18-4ab9-bdeb-372650039cbb 38 fields · synced Jun 8, 2026