FDA 510(k)

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella

K-번호: K243656 · 2025-07-31

결정일2025-07-31

제품 코드MBH

자문 위원회OR

결정Substantially Equivalent

기기 요약

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243656. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is United Orthopedic Corporation. The 510(k) number is K243656.

When did U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella receive FDA 510(k) clearance?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243656.

Who is the listed applicant for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

The FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is MBH.

United Orthopedic Corporation를 신청인으로 등재한 기타 기록

K253948Momentum Acetabular Cup System K252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K242315Resolve Modular Revision Hip Stem K243466Conformity Stem Extension Line, #0 K243024Cellbrick Knee Spacer

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