UTS Stem, Ti plasma spray, high offset

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name: UTS Stem, Ti plasma spray, high offset FDA UDI
Generic Name: Revision coated hip femur prosthesis FDA UDI
Device Name: UTS Stem, Ti plasma spray, high offset, #8 FDA UDI
Model / Reference: 1106-5208 FDA UDI
Description: UTS Stem, Ti plasma spray, high offset, #8 FDA UDI

Identifiers

Catalog Number: 1106-5208 FDA UDI
Primary DI / UDI-DI: 04719872156413 FDA UDI
510(k) Number: K172251 FDA UDI
FDA Product Code: KWY FDA UDI
LZO FDA UDI
LPH FDA UDI
GMDN Term: Revision coated hip femur prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
888.3353 FDA UDI
888.3358 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

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

Category: Coated hip femur prosthesis, modular Revision coated hip femur prosthesis

UTS Stem, Ti plasma spray, high offset by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Revision coated hip femur prosthesis.

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Cleared under the same submission

K172251 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: United Orthopedic Corp.

Sources (1)

FDA UDI e63c008b-07df-4e02-9be1-3deaa11667bb 37 fields · synced Jun 8, 2026