FDA 510(k)

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

K-번호: K202806 · 2021-06-17

결정일2021-06-17

제품 코드MAI

자문 위원회OR

결정Substantially Equivalent

기기 요약

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K202806. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K202806.

When did Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) receive FDA 510(k) clearance?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) received FDA 510(k) clearance on 2021-06-17, under 510(k) number K202806.

Who is the listed applicant for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

The FDA 510(k) record lists Osteonic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

The FDA product code for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is MAI.

Osteonic Co., Ltd.를 신청인으로 등재한 기타 기록

K254182아스터 K243469SIGNEX K243470Fix2Lock (PEEK Self Punching)K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)K230546SIGNEX K233659Suture Wing

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