FDA 510(k)

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

K-Nummer: K192718 · 2019-12-20

AntragstellerPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

Entscheidungsdatum2019-12-20

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. als Antragsteller

K201497EVOS Cabling System 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 K183060CervAlign™ Anterior Cervical Plate System

Alle 13 Geräte anzeigen →

Verwandte Geräte (Code: MAX)

K261049SCALA® TLSpineart SA 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 SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.