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Sheffield Ring Fixator

FDA UDI

Class II (US FDA UDI)

by Orthofix, Inc.

Identity

Trade Name
SHEFFIELD RING FIXATOR FDA UDI
Generic Name
External orthopaedic fixation system, reusable FDA UDI
Device Name
THREADED BARS LENGTH 160 MM (SET OF 3) FDA UDI
Model / Reference
1 FDA UDI
Description
THREADED BARS LENGTH 160 MM (SET OF 3) FDA UDI

Identifiers

Catalog Number
80038 FDA UDI
Primary DI / UDI-DI
18032568860351 FDA UDI
510(k) Number
K944092 FDA UDI
FDA Product Code
JEC FDA UDI
GMDN Term
External orthopaedic fixation system, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

Dimensions & Sizes

Size
Width — 34 Millimeter FDA UDI

Category: External orthopaedic fixation system, reusable

Sheffield Ring Fixator by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, reusable.

Cleared under the same submission

K944092 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthofix, Inc.

Sources (1)

  • FDA UDI 123d6d92-95cb-45ff-9ddf-0b9e601da6d2 37 fields · synced May 30, 2026