510(k) Report

Devices descending from K963639

414 later devices reach Acromed Pedicle Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K252437JAZZ Spinal SystemImplanet20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+11K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+11K182470Plateau Spacer SystemLife Spine20180—
+12K222362Salvo® Spine SystemSpine Wave, Inc.20223—