FDA 510(k)

Tactoset® Injectable Bone Substitute

K-번호: K231968 · 2023-12-20

결정일2023-12-20

제품 코드MQV

자문 위원회OR

결정Substantially Equivalent

기기 요약

Tactoset® Injectable Bone Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231968. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Tactoset® Injectable Bone Substitute?

Tactoset® Injectable Bone Substitute is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Anika Therapeutics, Inc.. The 510(k) number is K231968.

When did Tactoset® Injectable Bone Substitute receive FDA 510(k) clearance?

Tactoset® Injectable Bone Substitute received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231968.

Who is the listed applicant for Tactoset® Injectable Bone Substitute?

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

What is the FDA product code for Tactoset® Injectable Bone Substitute?

The FDA product code for Tactoset® Injectable Bone Substitute is MQV.

Anika Therapeutics, Inc.를 신청인으로 등재한 기타 기록

K261869Integrity Retractable Implant Inserter (6000127)K261311HYALOMATRIX K250997Integrity™ Implant K223538Integrity Implant K223860Integrity™ Bone Staple Fixation System K222487Anika 조직 탭 고정 시스템

11개 장치 모두 보기 →

관련 기기 (코드: MQV)

공식 출처

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