The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
Device ID | BK180180 |
510k Number | BK180180 |
Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
Classification | Platelet And Plasma Separator For Bone Graft Handling |
Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 US |
Product Code | ORG |
CFR Regulation Number | 864.9245 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-08 |
Decision Date | 2018-07-05 |