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FDA 510(k)

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology

K-Number: K172343 · 2017-10-23

ApplicantRti Surgical, Inc.
Decision Date2017-10-23
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology is a medical device manufactured by Rti Surgical, Inc.. It received FDA 510(k) clearance on 2017-10-23 under approval number K172343. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology?

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Rti Surgical, Inc.. The 510(k) number is K172343.

When was Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology approved by the FDA?

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology received FDA 510(k) clearance on 2017-10-23, under approval number K172343.

What company makes Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology?

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology is manufactured by Rti Surgical, Inc..

What is the FDA product code for Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology?

The FDA product code for Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT06335082 A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025)

Other Devices by Rti Surgical, Inc.

K163673Fortilink™-C with TETRAfuse™ 3D Technology K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) K253145Pre-Sutured Tendon K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCC

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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