FDA 510(k)

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

K-번호: K251686 · 2025-10-30

결정일2025-10-30

제품 코드KWT

자문 위원회OR

결정Substantially Equivalent

기기 요약

Tornier Humeral Reconstruction System Max (Tornier HRS Max) is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K251686. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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

Tornier Humeral Reconstruction System Max (Tornier HRS Max) is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Tornier, Inc.. The 510(k) number is K251686.

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

Tornier Humeral Reconstruction System Max (Tornier HRS Max) received FDA 510(k) clearance on 2025-10-30, under 510(k) number K251686.

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

The FDA 510(k) record lists 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 Max (Tornier HRS Max)?

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

Tornier, Inc.를 신청인으로 등재한 기타 기록

K260721Tornier Perform Advanced Glenoid K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K230352Tornier Humeral Nail and Tornier Long Humeral Nail K220914Tornier Perform Humeral System – Fracture K220418Tornier Perform Humeral System – Stemless K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

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