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Tara Femoral Component 47

FDA UDI

Class II (US FDA UDI)

by Biopro, Inc.

Identity

Trade Name
TARA FEMORAL COMPONENT 47 FDA UDI
Generic Name
Resurfacing metallic hip prosthesis FDA UDI
Model / Reference
10089 FDA UDI

Identifiers

Primary DI / UDI-DI
M209100890 FDA UDI
510(k) Number
K043542 FDA UDI
FDA Product Code
KXA FDA UDI
GMDN Term
Resurfacing metallic hip prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3400 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Resurfacing metallic hip prosthesis

Tara Femoral Component 47 by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resurfacing metallic hip prosthesis.

Cleared under the same submission

K043542 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biopro, Inc.

Sources (1)

  • FDA UDI a52b80aa-6164-4e40-8f98-2b83b4a68b90 33 fields · synced May 30, 2026