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B-P Total Hip System

FDA UDI

Class II (US FDA UDI)

by Endotec, Inc.

Identity

Trade Name
B-P TOTAL HIP SYSTEM FDA UDI
Generic Name
Resurfacing metallic hip prosthesis FDA UDI
Device Name
B-P HIP FEMORAL RESURFACING CUP W/BIOCOAT & W/ULTRACOAT - 36.5 MM FDA UDI
Model / Reference
01-03-0036 FDA UDI
Description
B-P HIP FEMORAL RESURFACING CUP W/BIOCOAT & W/ULTRACOAT - 36.5 MM FDA UDI

Identifiers

Catalog Number
01-03-0036 FDA UDI
Primary DI / UDI-DI
00814193023001 FDA UDI
510(k) Number
K904870 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 36.5 Millimeter FDA UDI

Category: Resurfacing metallic hip prosthesis

B-P Total Hip System by Endotec, 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

K904870 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endotec, Inc.

Sources (1)

  • FDA UDI 27c137e3-6c84-44ff-93c8-911303b2fbad 37 fields · synced Jun 8, 2026