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510(k) K230608

SPICCA Stand-Alone Cervical Fusion Cages by Southern Medical (Pty) , Ltd. — Product Code OVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2023
Date Received
March 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, 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 with or without supplemental fixation.

Other clearances by Southern Medical (Pty) , Ltd.

  • K253373 — Southern Craniomaxillofacial (CMF) System (December 19, 2025)
  • K230607 — SPICCA Cervical Fusion Cages (August 14, 2023)
  • K231145 — Axis Anterior Cervical Plate System (June 13, 2023)
  • K221182 — Southern Transforaminal Lumbar Interbody Fusion (TLIF) (December 8, 2022)
  • K221447 — Southern Anterior Screw Fixated Cage (SASCA) (October 14, 2022)

Other clearances for product code OVE

  • K260038 — E3D™-C Interbody System (February 4, 2026)
  • K253876 — HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (December 22, 2025)
  • K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
  • K250076 — Endeavor™ Stand-Alone Cervical IBF System (September 25, 2025)
  • K250540 — SABER-C System (August 8, 2025)
  • K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
  • K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
  • K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
  • K242928 — Tesera-k SC System (April 10, 2025)
  • K243188 — CYLOX® ST (February 11, 2025)