FDA 510(k)

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

K-번호: K252352 · 2026-01-22

결정일2026-01-22

제품 코드PHX

자문 위원회OR

결정Substantially Equivalent

기기 요약

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K252352. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K252352.

When did SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System receive FDA 510(k) clearance?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252352.

Who is the listed applicant for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

The FDA product code for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is PHX.

Lima Corporate S.P.A.를 신청인으로 등재한 기타 기록

K251718ArTT Augments and Buttresses and Bone Screws K243826SMR Reverse HP Shoulder System K250980Physica System (Physica CR Porous Femoral components)K243615Physica Porous Femoral Components K234011AMF TT Cones K233712PRIMA Humeral System; PRIMA TT Glenoid

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