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: Coated femoral stem prosthesis, modular FDA UDI
Device Name: Tapered Femoral Stem, Std Offset, 18mm FDA UDI
Model / Reference: A 400 FDA UDI
Description: Tapered Femoral Stem, Std Offset, 18mm FDA UDI

Identifiers

Catalog Number: 1401-322-180 FDA UDI
Primary DI / UDI-DI: 00841523102624 FDA UDI
510(k) Number: K112897 FDA UDI
FDA Product Code: OQI FDA UDI
OQG FDA UDI
LZO FDA UDI
LPH FDA UDI
GMDN Term: Coated femoral stem prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Coated femoral stem prosthesis, modular

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 Coated femoral stem prosthesis, modular.

MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II
MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Alteon — Exactech, Inc. · Class II
ANTHOLOGY — Smith & Nephew, Inc. · Class III
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II

Cleared under the same submission

K112897 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Kyocera Medical Technologies, Inc.

Sources (1)

FDA UDI 7ffd80c5-8d5b-4cb9-bb37-a56e5ff395e7 35 fields · synced Jun 8, 2026