510(k) Report

Devices descending from K962397

531 later devices reach Statak Soft Tissue Attachment Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+11K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+11K180500VariAx 2 SystemStryker GmbH201812—
+12K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+12K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+12K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+12K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+12K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+13K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+13K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+13K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+14K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+14K233919VariAx 2 Distal Radius SystemStryker GmbH20242—