FDA 510(k)

KMTI S141 Lumbar Interbody Fusion System

K-번호: K212070 · 2021-08-30

결정일2021-08-30

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

KMTI S141 Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-08-30 under 510(k) number K212070. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the KMTI S141 Lumbar Interbody Fusion System?

KMTI S141 Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2021-08-30. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K212070.

When did KMTI S141 Lumbar Interbody Fusion System receive FDA 510(k) clearance?

KMTI S141 Lumbar Interbody Fusion System received FDA 510(k) clearance on 2021-08-30, under 510(k) number K212070.

Who is the listed applicant for KMTI S141 Lumbar Interbody Fusion System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KMTI S141 Lumbar Interbody Fusion System?

The FDA product code for KMTI S141 Lumbar Interbody Fusion System is MAX.

Kyocera Medical Technologies, Inc.를 신청인으로 등재한 기타 기록

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