510(k) Report

Devices descending from K132154

11 later devices reach Capsure PS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172175CapSure® PS SystemSpine Wave, Inc.20170—
+1K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+1K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+2K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+2K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+2K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K222362Salvo® Spine SystemSpine Wave, Inc.20223—