Home / 510(k) Clearances / K133815

510(k) K133815

INTESS CERVICAL CAGE SYSTEM by Kalitec Direct, LLC — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2014
Date Received
December 16, 2013
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 Kalitec Direct, LLC

  • K180401 — TiWAVE-C™ Porous Titanium Cervical Cage (June 14, 2018)
  • K172808 — CosmoLock Pedicle Screw System (October 25, 2017)
  • K172086 — Matira™ Anterior Cervical System (September 22, 2017)
  • K170342 — Ocata Anterior Cervical System (May 9, 2017)
  • K163471 — Kalitec Direct InSePtion™ MIS Fixation System (March 16, 2017)
  • K140678 — COSMOLOCK PEDICLE SCREW SYSTEM (June 19, 2014)
  • K123100 — INTESS LUMBAR CAGE (March 28, 2013)
  • K111370 — ODALYS PEDICLE SCREW SYSTEM (September 21, 2011)

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)