510(k) Report

Devices descending from K132925

23 later devices reach Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+1K161842Overwatch Spine SystemAmendia, Inc.201661
+1K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+1K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—