FDA 510(k)

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

K-번호: K172326 · 2017-10-30

결정일2017-10-30

제품 코드JWH

자문 위원회OR

결정Substantially Equivalent

기기 요약

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K172326. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System?

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Stryker Orthopaedics. The 510(k) number is K172326.

When did Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System receive FDA 510(k) clearance?

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System received FDA 510(k) clearance on 2017-10-30, under 510(k) number K172326.

Who is the listed applicant for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System?

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

What is the FDA product code for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System?

The FDA product code for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System is JWH.

Stryker Orthopaedics를 신청인으로 등재한 기타 기록

K211703Insignia Hip Stem K191414EXETER Centralizer, EXETER 2.5mm Plug K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads K173849Triathlon Total Knee System K153345Stryker Orthopaedics Hip Systems Labeling Update

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