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U-Motion II

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1406-6651

by United Orthopedic Corp.

Identity

Trade Name
U-Motion II EUDAMEDFDA UDI
Generic Name
Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
Device Name
U-Motion II Acetabular liner trial, 20°, ID36mm, OD50mm EUDAMEDFDA UDI
Model / Reference
1406-6651 EUDAMEDFDA UDI
Description
U-Motion II Acetabular liner trial, 20°, ID36mm, OD50mm FDA UDI

Identifiers

Catalog Number
1406-6651 FDA UDI
Primary DI / UDI-DI
04719872162049 EUDAMEDFDA UDI
Basic UDI-DI
B-04719872162049 EUDAMED
510(k) Number
K170089 FDA UDI
K172833 FDA UDI
FDA Product Code
JDI FDA UDI
OQI FDA UDI
MEH FDA UDI
KWY FDA UDI
LZO FDA UDI
LWJ FDA UDI
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Acetabulum prosthesis trial, prefabricated, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
888.3350 FDA UDI
888.3353 FDA UDI
888.3390 FDA UDI
888.3360 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

U-Motion II by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K170089 also covers:

K172833 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
United Orthopedic Corp.

Sources (2)

  • FDA UDI e0518dcf-d455-4a74-ba12-c799b7ea78d5 37 fields · synced Oct 7, 2026
  • EUDAMED 1a5e80e6-5ce8-4615-abdf-b35dacbb7ce2 61 fields · synced Jul 20, 2026