510(k) Report

Devices descending from K201073

17 later devices reach Seaspine WaveForm C Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+1K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+2K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+2K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+2K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+2K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—