510(k) Report

Devices descending from K081730

705 later devices reach Novel Cervical Spinal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—