← 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
Ceramic-on-polyethylene total hip prosthesis FDA UDI
Device Name
B-P HIP FEMORAL STEM W/O HEAD, W/O BIOCOAT & W/ULTRACOAT - 10 MM FDA UDI
Model / Reference
01-04-0410 FDA UDI
Description
B-P HIP FEMORAL STEM W/O HEAD, W/O BIOCOAT & W/ULTRACOAT - 10 MM FDA UDI

Identifiers

Catalog Number
01-04-0410 FDA UDI
Primary DI / UDI-DI
00814193023223 FDA UDI
510(k) Number
K884789 FDA UDI
FDA Product Code
KWL FDA UDI
GMDN Term
Ceramic-on-polyethylene total hip prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3360 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
Width — 10 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

K884789 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 71bbacc1-df56-4742-885a-2933fd8b9b64 38 fields · synced Jun 6, 2026