510(k) Premarket Notification | 合法醫療器材資訊網
2021年6月17日—triathlon®x3®uhmwpetibialinsertsandpatellarcomponents17,HowmedicaOsteonicsCorpakaStrykerOrthopaedics,K17263418,11/16/ ...
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
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References Learn more... (www.fda.gov)
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K172634 | 合法醫療器材資訊網
2017年11月16日 — Re: K172634. Trade/Device Name: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. Regulation Number: 21 CFR 888.3565. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
2017年11月16日 — ... prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer22. 510(k) Number, K172634. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
2021年6月17日 — triathlon® x3® uhmwpe tibial inserts and patellar components17, Howmedica Osteonics Corp aka Stryker Orthopaedics, K17263418, 11/16/ ... Read More
Triathlon® X3® Uhmwpe Tibial Inserts And Patellar Components ... | 合法醫療器材資訊網
510k Number, K172634. Device Name: Triathlon® X3® UHMWPE Tibial Inserts And Patellar Components. Classification, Prosthesis, Knee, Patello/femorotibial, ... Read More
Laboratory Products Sales | 合法醫療器材資訊網
Catalog #, Description, 1-9 Price. K172634, Beta storage box w/foam insert, $181.73. ORDER QUANTITY: 30:59:55 - 1 Day Only. Deal of the Day - One Day ... Read More
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