510(k) Report

Devices descending from K162639

13 later devices reach Proficient™ Posterior Cervical Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172594Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.201712—
+2K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+2K181440Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.20184—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—