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Stryker Spine

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories7
Latest Approval2026-04-24
TypeNumberDevice NameCodeDate
510(k) K261008 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute MQV 2026-04-24 View
510(k) K242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI KWQ 2024-11-07 View
510(k) K242280 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips MQV 2024-08-29 View
510(k) K222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi NKB 2023-06-08 View
510(k) K221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer ODP 2023-02-14 View
510(k) K203205 Navigated Spine Instruments OLO 2021-03-23 View
510(k) K200666 Stryker Xia 3 Power Adaptor NKB 2020-04-23 View
510(k) K183249 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage MAX 2019-07-25 View
510(k) K183071 VLIFT-s Vertebral Body Replacement System PLR 2019-01-10 View
510(k) K181014 Tritanium PL Cage MAX 2018-07-18 View
510(k) K171496 Tritanium C Anterior Cervical Cage ODP 2017-09-06 View
510(k) K161407 Ascential IBD PEEKc Spacer ODP 2016-07-15 View