510(k) Report

Devices descending from K151974

16 later devices reach Polaris Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+1K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+1K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+1K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K191575ARx Spinal SystemLife Spine, Inc.201910—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—