510(k) Report

Devices descending from K150822

23 later devices reach Centurion POCT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180025Centurion POCT SystemOrthofix, Inc.20186—
+1K170647Connector SystemOrthofix, Inc.201718—
+2K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+2K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+2K201481Centurion POCT SystemOrthofix, Inc.20203—
+2K200896Solstice CCILife Spine, Inc.20200—
+2K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+2K172194Connector SystemOrthofix, Inc.2017162
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K190751Connector SystemOrthofix, Inc.20193—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K233366SYMPHONY OCT SystemMedos International SARL20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—