510(k) Report

Devices descending from K171570

20 later devices reach Additional VIPER PRIME™ screws with fenestrations through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+2K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+2K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—