510(k) Premarket Notification | 合法醫療器材資訊網
2016年3月17日—restoration®modularhipsystem17,HowmedicaOsteonicsCorp....osteonicsomnifithahipstemseries,osteonicssecur-fithahipstemseries, ...
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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Restoration-HA-Surgical-Techniques | 合法醫療器材資訊網
The Restoration"" HA Hip System is designed to address the ... RestorationTM HA, PureFixTM HA and Cutting EdgeTM are trademarks of Howmedica Osteonics ... Read More
Class 2 Device Recall Restoration HA Reduced Neck | 合法醫療器材資訊網
2012年5月29日 — Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Restoration HA cementless Hip System is ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
2016年3月17日 — restoration® modular hip system17, Howmedica Osteonics Corp. ... osteonics omnifit ha hip stem series, osteonics secur-fit ha hip stem series, ... Read More
Class 3 Device Recall Stryker Howmedica Osteonics | 合法醫療器材資訊網
6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218. Code Information, Catalog No. 6013-1216 -- Lot Code: 37778302; Catalog No. 6013-1218 ... Read More
人工髖關節自費醫材之被替代健保給付特材品項對照檔 | 合法醫療器材資訊網
“Howmedica Osteonics”. Trident Acetabular ... OSTEONICS" SECUR-FIT. HA HIP SYSTEM:HA. SELL ... Osteonics"Restoration ADM and MDM Hip Component:. Read More
Howmedica Osteonics Restoration Ha Hip Stem 510(k) FDA ... | 合法醫療器材資訊網
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM. Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate. Read More
Femoral Revision with an Extensively Hydroxyapatite | 合法醫療器材資訊網
2007年12月1日 — ... stem for femoral revisions in patients with moderate to severe proximal femoral bone loss (Restoration HA, Stryker Howmedica Osteonics, ... Read More
Summary | 合法醫療器材資訊網
1999年9月7日 — Howmedica Osteonics® Restoration™ HA Hip Stems. Submission Information. Name and Address of the Sponsor of the 510(k) Submission:. Read More
Surgical Technique | 合法醫療器材資訊網
Additional indication specific to use of Secur-Fit Advanced Hip. Stems with compatible Howmedica Osteonics Constrained Liners: • When the stem is to be used ... Read More
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