510(k) Report

Devices descending from K183397

16 later devices reach ChoiceSpine Stealth Cervical Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+1K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+1K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+2K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—