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FDA 510(k)

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System

K-Number: K170643 · 2017-04-14

ApplicantRti Surgical, Inc. Dba Rti Biologics
Decision Date2017-04-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is a medical device manufactured by Rti Surgical, Inc. Dba Rti Biologics. It received FDA 510(k) clearance on 2017-04-14 under approval number K170643. 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 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is a medical device that received FDA 510(k) clearance on 2017-04-14. It is manufactured by Rti Surgical, Inc. Dba Rti Biologics. The 510(k) number is K170643.

When was Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System approved by the FDA?

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System received FDA 510(k) clearance on 2017-04-14, under approval number K170643.

What company makes Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is manufactured by Rti Surgical, Inc. Dba Rti Biologics.

What is the FDA product code for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

The FDA product code for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

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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