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"UNITED" USTAR II Knee System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 2315-3246

by United Orthopedic Corp.

Identity

Trade Name
USTAR II Knee System EUDAMED
"UNITED" USTAR II Knee System FDA UDI
Generic Name
Rotating hinged total knee prosthesis FDA UDI
Device Name
USTAR II Knee System XPE Tibial Insert, M, 26mm EUDAMED
XPE Tibial insert, M, 26mm FDA UDI
Model / Reference
2315-3246 EUDAMEDFDA UDI
Description
XPE Tibial insert, M, 26mm FDA UDI

Identifiers

Primary DI / UDI-DI
04711605580427 EUDAMEDFDA UDI
Basic UDI-DI
B-04711605580427 EUDAMED
510(k) Number
K190100 FDA UDI
FDA Product Code
KRO FDA UDI
LPH FDA UDI
LWJ FDA UDI
KWL FDA UDI
EMDN Code
P090906 KNEE PROSTHESES FOR LARGE RESECTIONS EUDAMED
GMDN Term
Rotating hinged total knee prosthesis FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
888.3510 FDA UDI
888.3358 FDA UDI
888.3360 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

"UNITED" USTAR II Knee System by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K190100 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 1bd88fa1-63e3-447d-a896-4a694fbc131c 35 fields · synced Oct 7, 2026
  • EUDAMED efa7a539-498c-4b38-84d9-872fc2ce43bf 61 fields · synced Jul 9, 2026