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

Clearance record K170452

Medacta Shoulder System · Medacta International S.A. · decided 2017-10-05 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Shoulder System04.01.0170Medacta International SAPHX07630040706575
Shoulder System04.01.0172Medacta International SAPHX07630040706599
Shoulder System04.01.0119Medacta International SAPHX07630040706261
Shoulder System04.01.0115Medacta International SAPHX07630040706223
Shoulder System04.01.0157Medacta International SAPHX07630040706445
Shoulder System04.01.0116Medacta International SAPHX07630040706230
Shoulder System04.01.0171Medacta International SAPHX07630040706582
Shoulder System04.01.0114Medacta International SAPHX07630040706216
Shoulder System04.01.0177Medacta International SAPHX07630040706636
Shoulder System04.01.0126Medacta International SAPHX07630040706339
Shoulder System04.01.0169Medacta International SAPHX07630040706568
Shoulder System04.01.0120Medacta International SAPHX07630040706278
Shoulder System04.01.0112Medacta International SAPHX07630040706193
Shoulder System04.01.0164Medacta International SAPHX07630040706513
Shoulder System04.01.0151Medacta International SAPHX07630040706384
Shoulder System04.01.0118Medacta International SAPHX07630040706254
Shoulder System04.01.0167Medacta International SAPHX07630040706544
Shoulder System04.01.0156Medacta International SAPHX07630040706438
Shoulder System04.01.0150Medacta International SAPHX07630040706377
Shoulder System04.01.0148Medacta International SAPHX07630040706353
Shoulder System04.01.0160Medacta International SAPHX07630040706476
Shoulder System04.01.0174Medacta International SAPHX07630040706612
Shoulder System04.01.0159Medacta International SAPHX07630040706469
Shoulder System04.01.0127Medacta International SAPHX07630040706346
Shoulder System04.01.0113Medacta International SAPHX07630040706209