FDA 510(k)

알로마트릭스 (알로마트릭스 주입용 푸티; 알로마트릭스 C; 알로마트릭스 DR; 알로마트릭스 커스텀)

K-번호: K252085 · 2025-09-30

신청자Wright Medical Technology, Inc. (Stryker Corporation)

결정일2025-09-30

제품 코드MQV

자문 위원회OR

결정Substantially Equivalent

기기 요약

Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Technology, Inc. (Stryker Corporation). It received FDA 510(k) clearance on 2025-09-30 under 510(k) number K252085. 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 Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)?

Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) is a medical device that received FDA 510(k) clearance on 2025-09-30. The listed applicant is Wright Medical Technology, Inc. (Stryker Corporation). The 510(k) number is K252085.

When did Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) receive FDA 510(k) clearance?

Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) received FDA 510(k) clearance on 2025-09-30, under 510(k) number K252085.

Who is the listed applicant for Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)?

The FDA 510(k) record lists Wright Medical Technology, Inc. (Stryker Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)?

The FDA product code for Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) is MQV.

Wright Medical Technology, Inc. (Stryker Corporation)를 신청인으로 등재한 기타 기록

K251643Synchfix EVT

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