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Biocore9 Femoral Resurfacing Component

FDA UDI

Class II (US FDA UDI)

by Biocore9, LLC

Identity

Trade Name
Biocore9 Femoral Resurfacing Component FDA UDI
Generic Name
Resurfacing metallic femoral head prosthesis FDA UDI
Device Name
Biocore9 Femoral Resurfacing Head Component 44 mm FDA UDI
Model / Reference
Femoral Resurfacing Component - 44 mm FDA UDI
Description
Biocore9 Femoral Resurfacing Head Component 44 mm FDA UDI

Identifiers

Catalog Number
01-03-0044 FDA UDI
Primary DI / UDI-DI
00810068850413 FDA UDI
510(k) Number
K201219 FDA UDI
FDA Product Code
KXA FDA UDI
GMDN Term
Resurfacing metallic femoral head 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 44 Millimeter FDA UDI

Category: Resurfacing metallic femoral head prosthesis

Biocore9 Femoral Resurfacing Component by Biocore9, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resurfacing metallic femoral head prosthesis.

Cleared under the same submission

K201219 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocore9, LLC

Sources (1)

  • FDA UDI 9dad2720-397e-45b8-88ab-4253fc88c3e6 37 fields · synced Jun 8, 2026