FDA 510(k)

Tornier Humeral Reconstruction System (Tornier HRS)

K-번호: K241609 · 2024-09-10

결정일2024-09-10

제품 코드KWS

자문 위원회OR

결정Substantially Equivalent

기기 요약

Tornier Humeral Reconstruction System (Tornier HRS) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, Inc.). It received FDA 510(k) clearance on 2024-09-10 under 510(k) number K241609. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Tornier Humeral Reconstruction System (Tornier HRS)?

Tornier Humeral Reconstruction System (Tornier HRS) is a medical device that received FDA 510(k) clearance on 2024-09-10. The listed applicant is Stryker Corporation (Tornier, Inc.). The 510(k) number is K241609.

When did Tornier Humeral Reconstruction System (Tornier HRS) receive FDA 510(k) clearance?

Tornier Humeral Reconstruction System (Tornier HRS) received FDA 510(k) clearance on 2024-09-10, under 510(k) number K241609.

Who is the listed applicant for Tornier Humeral Reconstruction System (Tornier HRS)?

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

What is the FDA product code for Tornier Humeral Reconstruction System (Tornier HRS)?

The FDA product code for Tornier Humeral Reconstruction System (Tornier HRS) is KWS.

Stryker Corporation (Tornier, Inc.)를 신청인으로 등재한 기타 기록

K260102Tornier Perform Reversed Glenoid 및 Tornier Perform Reversed Augmented Glenoid Shoulder System K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

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