510(k) Report

Devices descending from K112444

324 later devices reach Anatomic Peek Cervical Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—