Home / 510(k) Clearances / K202393

510(k) K202393

SpineJack Expansion Kit by Stryker Corporation — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2020
Date Received
August 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

Other clearances by Stryker Corporation

  • K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management Sys (August 18, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)
  • K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker an (February 16, 2023)
  • K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ A (October 19, 2022)
  • K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Devic (September 16, 2022)
  • K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Ele (July 12, 2022)
  • K213824 — Sonopet iQ Ultrasonic Aspirator System (February 3, 2022)
  • K212055 — Connected OR Hub with Device and Voice Control (December 16, 2021)
  • K210377 — Stryker iBur hubs and cutting accessories (June 30, 2021)
  • K202964 — iBed Wireless with iBed Mobile (June 18, 2021)

Other clearances for product code NDN

  • K251896 — XeliteMed SuperM-Fix Spinal Bone Cement (January 28, 2026)
  • K250637 — VCFix Spinal System (May 30, 2025)
  • K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (April 11, 2025)
  • K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement (September 18, 2024)
  • K232842 — Balloon Inflation System (February 29, 2024)
  • K240084 — V-STRUT® Vertebral Implant (February 9, 2024)
  • K231340 — Renova Spine Balloon Catheter (October 30, 2023)
  • K221697 — INJECTION PIN (KIP(02031-02061) (03031-03061)) (March 3, 2023)
  • K223294 — SpineJack® Expansion Kit (December 20, 2022)
  • K220131 — KYPHON VuE Bone Cement (April 18, 2022)