← Back to catalogue

Kyocera Medical Technologies, Inc.

FDA UDI

Class II (US FDA UDI)

by Kyocera Medical Technologies, Inc.

Identity

Trade Name
Kyocera Medical Technologies, Inc. FDA UDI
Generic Name
Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Device Name
Bipolar Implant 61mm OD - 28mm ID FDA UDI
Model / Reference
Bipolar Hip FDA UDI
Description
Bipolar Implant 61mm OD - 28mm ID FDA UDI

Identifiers

Catalog Number
1416-028-061 FDA UDI
Primary DI / UDI-DI
00841523105571 FDA UDI
510(k) Number
K131354 FDA UDI
FDA Product Code
KWY FDA UDI
GMDN Term
Bipolar femoral head outer component, hemiarthroplasty FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3390 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

Category: Bipolar femoral head outer component, hemiarthroplasty

Kyocera Medical Technologies, Inc. by Kyocera Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bipolar femoral head outer component, hemiarthroplasty.

Cleared under the same submission

K131354 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
Kyocera Medical Technologies, Inc.

Sources (1)

  • FDA UDI ab5cfae2-87fa-4b11-8a8f-23c0f12f41eb 35 fields · synced Jun 8, 2026