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510(k) K163673

Fortilink™-C with TETRAfuse™ 3D Technology by Rti Surgical, Inc. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2017
Date Received
December 27, 2016
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 Rti Surgical, Inc.

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  • K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (February 21, 2025)
  • K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadru (June 23, 2023)
  • K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (October 23, 2017)
  • K142070 — FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS (October 27, 2014)
  • K132850 — BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE P (March 31, 2014)

Other clearances for product code ODP

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  • 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)