FDA 510(k)

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology

K-Number: K192718 · 2019-12-20

ApplicantPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

Decision Date2019-12-20

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192718. 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 Device (IBF) with TETRAfuse 3D Technology?

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K192718.

When did Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology receive FDA 510(k) clearance?

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192718.

Who is the listed applicant for Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology?

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

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

The FDA product code for Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology 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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. as applicant

K201497EVOS Cabling System K200513DAC Dynamic Active Compression Plate K200095Streamline Navigated Instruments K193468Tritium Sternal Cable Plate System K192800Streamline TL Spinal Fixation System K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System

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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

View on FDA Database →

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