510(k) Report

Devices descending from K990745

916 later devices reach Modification to Synthes Universal Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+11K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+11K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+11K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+11K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+12K250769Dakota LP SystemPrecision Spine, Inc.20250—
+12K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+12K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+12K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+12K230329F3D Interbody SystemCorelink, LLC20230—
+13K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+13K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+14K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—