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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
Bipolar humeral head outer component FDA UDI
Device Name
B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 75 MM FDA UDI
Model / Reference
01-16-0312 FDA UDI
Description
B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 75 MM FDA UDI

Identifiers

Catalog Number
01-16-0312 FDA UDI
Primary DI / UDI-DI
00814193024077 FDA UDI
510(k) Number
K905262 FDA UDI
FDA Product Code
JDI FDA UDI
GMDN Term
Bipolar humeral head outer component FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3350 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
Length — 75 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI

Category: Bipolar femoral head outer component, hemiarthroplastyCeramic-on-polyethylene total hip prosthesisBipolar humeral head outer component

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 Bipolar humeral head outer component.

Cleared under the same submission

K905262 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 dcc05d68-d9d0-4d56-8db6-6e84be288747 37 fields · synced Jun 1, 2026