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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K161616

DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw · Synthes USA Products, LLC · decided 2017-02-16 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
(unnamed)406.426Synthes GmbHHRS HWC10886982207777
(unnamed)208.403Synthes GmbHHWC10886982149107
(unnamed)04.226.219SSynthes GmbHHWC10886982122513
(unnamed)02.226.119Synthes GmbHHWC10886982058249
(unnamed)02.226.023Synthes GmbHHWC10886982057921
(unnamed)209.980SSynthes GmbHHWC10886982151476
(unnamed)208.830Synthes GmbHHWC10886982149893
(unnamed)208.474Synthes GmbHHWC10886982149756
(unnamed)04.226.134Synthes GmbHHWC10886982122223
(unnamed)408.442Synthes GmbHHWC10886982209221
(unnamed)208.466Synthes GmbHHWC10886982149671
(unnamed)208.425Synthes GmbHHWC10886982149329
(unnamed)04.226.652SSynthes GmbHHWC10886982123558
(unnamed)04.226.219Synthes GmbHHWC10886982122506
(unnamed)02.226.229Synthes GmbHHWC10886982058980
(unnamed)409.690Synthes GmbHHWC10886982210036
(unnamed)408.410Synthes GmbHHWC10886982208927
(unnamed)208.950Synthes GmbHHWC10886982150134
(unnamed)208.100Synthes GmbHHWC10886982148971
(unnamed)04.226.640Synthes GmbHHWC10886982123428
(unnamed)408.413Synthes GmbHHWC10886982208958
(unnamed)209.050Synthes GmbHHWC10886982150271
(unnamed)208.475Synthes GmbHHWC10886982149763
(unnamed)04.230.118SSynthes GmbHHWC10886982125453
(unnamed)04.226.238SSynthes GmbHHWC10886982122810