← Back to catalogue

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 - 9 MM X 125 MM FDA UDI
Model / Reference
01-16-0509 FDA UDI
Description
B-P MODULAR EXTENSION W/ULTRACOAT - 9 MM X 125 MM FDA UDI

Identifiers

Catalog Number
01-16-0509 FDA UDI
Primary DI / UDI-DI
00814193024282 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 — 125 Millimeter FDA UDI
Width — 9 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Endotec, Inc.

Sources (1)

  • FDA UDI 5b685534-f3d7-4531-af76-714ffc3c7f45 37 fields · synced Jun 6, 2026