FDA 510(k)

Tesera-k PL System and Tesera-k XL System

K-번호: K242771 · 2025-03-20

결정일2025-03-20

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

Tesera-k PL System and Tesera-k XL 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 2025-03-20 under 510(k) number K242771. 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 Tesera-k PL System and Tesera-k XL System?

Tesera-k PL System and Tesera-k XL System is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K242771.

When did Tesera-k PL System and Tesera-k XL System receive FDA 510(k) clearance?

Tesera-k PL System and Tesera-k XL System received FDA 510(k) clearance on 2025-03-20, under 510(k) number K242771.

Who is the listed applicant for Tesera-k PL System and Tesera-k XL 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 Tesera-k PL System and Tesera-k XL System?

The FDA product code for Tesera-k PL System and Tesera-k XL System is MAX.

Kyocera Medical Technologies, Inc.를 신청인으로 등재한 기타 기록

K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System K242045이니셔티 T3 acetabulum 반구형 셸 시스템 K242928Tesera-k SC System K243295초기膝关节 시스템 K243015Skyway Anterior Cervical Plate System K232114TRIBRID® Unicompartmental Knee System

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