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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
Ceramic-on-polyethylene total hip prosthesis FDA UDI
Device Name
B-P HIP ACETABULAR BEARING - 44 MM I.D. X 56 MM O.D. FDA UDI
Model / Reference
01-02-4456 FDA UDI
Description
B-P HIP ACETABULAR BEARING - 44 MM I.D. X 56 MM O.D. FDA UDI

Identifiers

Catalog Number
01-02-4456 FDA UDI
Primary DI / UDI-DI
00814193022929 FDA UDI
510(k) Number
K963101 FDA UDI
FDA Product Code
JDI FDA UDI
LPH FDA UDI
GMDN Term
Ceramic-on-polyethylene total hip prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3350 FDA UDI
888.3358 FDA UDI
Commercial Distribution
Not 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 — 56 Millimeter FDA UDI
Lumen/Inner Diameter — 44 Millimeter FDA UDI

B-P Total Hip System by Endotec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K963101 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 2f1bb7c1-4618-4c79-b468-884a7188158d 38 fields · synced Jun 1, 2026