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

Clearance record K252950

Paradigm System · Proprio, Inc. · decided 2025-12-15 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Paradigm1200017Proprio, Inc.OLO00850042604205
Paradigm1200014Proprio, Inc.OLO00850042604175
Paradigm Navigated Drill Guide Case Tray1200022Proprio, Inc.OLO00850042604236
Paradigm1200004Proprio, Inc.OLO00850042604069
Paradigm Navigated Drill Guide Case Assembly1200021Proprio, Inc.OLO00850042604342
Paradigm Drill Bit, 3.0 mm1200026Proprio, Inc.OLO00850042604298
Paradigm1200006Proprio, Inc.OLO00850042604083
Paradigm1200012Proprio, Inc.OLO00850042604120
Paradigm1200016Proprio, Inc.OLO00850042604199
Paradigm1200008Proprio, Inc.OLO00850042604151
Paradigm1200005Proprio, Inc.OLO00850042604076
Paradigm1100006Proprio, Inc.OLO00850042604014
Paradigm Depth Cannula, 5mm1200030Proprio, Inc.OLO00850042604328
Paradigm1300001Proprio, Inc.OLO00850042604267
Paradigm Navigated Drill Guide Case Lid1200023Proprio, Inc.OLO00850042604243
Paradigm Drill Bit, 2.1 mm1200025Proprio, Inc.OLO00850042604281
Paradigm Navigated Drill Guide Set1200020Proprio, Inc.OLO00850042604335
Paradigm1200003Proprio, Inc.OLO00850042604052
Paradigm Foot Switch1100008Proprio, Inc.OLO00850042604366
Paradigm1200018Proprio, Inc.OLO00850042604212
Paradigm1200013Proprio, Inc.OLO00850042604168
Paradigm1200011Proprio, Inc.OLO00850042604113
Paradigm1200015Proprio, Inc.OLO00850042604182
Paradigm Depth Cannula, 2mm1200027Proprio, Inc.OLO00850042604304
Paradigm Navigated Drill Guide1200024Proprio, Inc.OLO00850042604274