Home / 510(k) Clearances / K161407

510(k) K161407

Ascential IBD PEEKc Spacer by Stryker Spine — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2016
Date Received
May 20, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Stryker Spine

  • K242361 — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal Sy (November 7, 2024)
  • K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioa (August 29, 2024)
  • K222684 — XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serr (June 8, 2023)
  • K221490 — Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Poste (February 14, 2023)
  • K203205 — Navigated Spine Instruments (March 23, 2021)
  • K200666 — Stryker Xia 3 Power Adaptor (April 23, 2020)
  • K183249 — Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curve (July 25, 2019)
  • K183071 — VLIFT-s Vertebral Body Replacement System (January 10, 2019)
  • K181014 — Tritanium PL Cage (July 18, 2018)
  • K171496 — Tritanium C Anterior Cervical Cage (September 6, 2017)

Other clearances for product code ODP

  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)
  • K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System (January 15, 2026)
  • K252219 — Cervical Interbody and VBR Fusion System (January 14, 2026)
  • K252711 — Advantage-C™ Ti3D Cervical Interbody Fusion Device (January 8, 2026)
  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252781 — MSFX MIKRON PEEK CAGES (December 19, 2025)
  • K250764 — SpineLinc Anterior Cervical Implant System (December 5, 2025)
  • K250769 — Dakota LP System (November 24, 2025)
  • K252686 — EffortMed PEEK Cages & Corpectomy Cages (November 21, 2025)