U2 Acetabular Components, HA/Ti Plasma Spray

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name: U2 Acetabular Components, HA/Ti Plasma Spray FDA UDI
Generic Name: Metal-on-polyethylene total hip prosthesis FDA UDI
Device Name: U2 Acetabular cup, HA/Ti plasma spray, Ø80mm FDA UDI
Model / Reference: 1303-5280 FDA UDI
Description: U2 Acetabular cup, HA/Ti plasma spray, Ø80mm FDA UDI

Identifiers

Catalog Number: 1303-5280 FDA UDI
Primary DI / UDI-DI: 04712602342391 FDA UDI
510(k) Number: K121777 FDA UDI
FDA Product Code: LPH FDA UDI
MEH FDA UDI
GMDN Term: Metal-on-polyethylene total hip prosthesis FDA UDI

Classification

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

Dimensions & Sizes

Size: Outer Diameter — 80 Millimeter FDA UDI

Category: Metal-on-polyethylene total hip prosthesis

U2 Acetabular Components, HA/Ti Plasma Spray by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metal-on-polyethylene total hip prosthesis.

Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
Libertas — MAXX ORTHOPEDICS INC. · Class II
Libertas — MAXX ORTHOPEDICS INC. · Class II
Cancellous Bone Screw with 6.5mm Head Diameter, 30mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
Conformis Hip System — Conformis, Inc. · Class II
Encompass Hip Stem — ORTHO DEVELOPMENT CORP. · Class II
Initia Total Hip System — Kyocera Corporation · Class II
Initia Total Hip System — Kyocera Corporation · Class II

Cleared under the same submission

K121777 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 f95f6331-9b47-4e59-95f2-f2a65c61fe66 37 fields · synced May 30, 2026