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Estremo

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name
ESTREMO FDA UDI
Generic Name
Orthopaedic bone-fragment manipulator, reusable FDA UDI
Model / Reference
Fracture alignment guide wire exchange tool FDA UDI

Identifiers

Catalog Number
EBA-5316 FDA UDI
Primary DI / UDI-DI
08052990979745 FDA UDI
510(k) Number
K181540 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Orthopaedic bone-fragment manipulator, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone-fragment manipulator, reusable

Estremo by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone-fragment manipulator, reusable.

Cleared under the same submission

K181540 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Citieffe

Sources (1)

  • FDA UDI a15ddd66-12db-4b33-8dce-e2658d433e2d 36 fields · synced May 30, 2026