Home / 510(k) Clearances / K172343

510(k) K172343

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology by Rti Surgical, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2017
Date Received
August 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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

Other clearances by Rti Surgical, Inc.

  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • 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)
  • K163673 — Fortilink™-C with TETRAfuse™ 3D Technology (May 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 MAX

  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)
  • K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac (January 23, 2026)
  • K253266 — Titanium Interbody System (January 8, 2026)
  • K253577 — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (December 19, 2025)
  • K252610 — ZSFab Lumbar Interbody System (November 25, 2025)
  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C (September 18, 2025)