Home / 510(k) Clearances / K122588

510(k) K122588

VUSION CS PLUS by Ortho Development Corp. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2013
Date Received
August 24, 2012
Clearance Type
Traditional
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 Ortho Development Corp.

  • K253161 — Balanced Knee System TriMax Porous Femoral Components (December 19, 2025)
  • K251052 — Trivicta® Hip Stem (May 22, 2025)
  • K242984 — BKS Revision System (October 25, 2024)
  • K242833 — Legend® Acetabular Shell (October 11, 2024)
  • K233758 — Trivicta™ Hip Stem (March 8, 2024)
  • K142146 — IBIS PEDICLE SCREW SYSTEM (December 11, 2014)
  • K141001 — ALPINE HIP STEM; ALPINE HA HIP STEM (July 30, 2014)
  • K132697 — ENCOMPASS 10/12 HIP STEM (June 20, 2014)
  • K133386 — OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM (March 11, 2014)
  • K133449 — KASM KNEE ARTICULATING SPACER MOLDS (February 18, 2014)

Other clearances for product code ODP

  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)
  • 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)