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: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: ACP, Ø4mm x 10mm, Fixed Angle Screw, Self-Tapping FDA UDI
Model / Reference: S 140 FDA UDI
Description: ACP, Ø4mm x 10mm, Fixed Angle Screw, Self-Tapping FDA UDI

Identifiers

Catalog Number: 1140-440-010 FDA UDI
Primary DI / UDI-DI: 00841523133048 FDA UDI
510(k) Number: K152193 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

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 Spinal fixation plate, non-bioabsorbable.

Zavation — ZAVATION · Class II
Cervalign — Xtant Medical Holdings, Inc. · Class II
CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
TSLP — Synthes · Class II
AESCULAP — AESCULAP, INC. · Class II
PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
ACP — Nuvasive, Inc. · Class II
uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II

Cleared under the same submission

K152193 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

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Manufacturer

Manufacturer: Kyocera Medical Technologies, Inc.

Sources (1)

FDA UDI 7c7bf95b-3a25-4a47-a765-03515eed3d58 35 fields · synced May 31, 2026