510(k) Report

Devices descending from K100044

117 later devices reach Firebird Spinal Fixation System, Firebird Side-Loading Body through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—