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 the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc. Dba Rti Biologics. It received FDA 510(k) clearance on 2017-04-14 under 510(k) 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. The listed applicant is Rti Surgical, Inc. Dba Rti Biologics. The 510(k) number is K170643.

When did Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System receive FDA 510(k) clearance?

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

Who is the listed applicant for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

The FDA 510(k) record lists Rti Surgical, Inc. Dba Rti Biologics as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03506334Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric ScoliosisENROLLING_BY_INVITATION NCT03965143Talus Replacement RegistryRECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 38273730Ten-Year Risk of Recall of Novel Spine Devices.Spine (2024)

Related Devices (Code: MAX)

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

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