FDA 510(k)

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

K-Nummer: K172343 · 2017-10-23

Entscheidungsdatum2017-10-23

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology is the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc.. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K172343. 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 (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. The listed applicant is Rti Surgical, Inc.. The 510(k) number is K172343.

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

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

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

The FDA 510(k) record lists 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 (IBF) System with TETRAfuse® 3D Technology?

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

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Weitere Einträge mit Rti Surgical, Inc. als Antragsteller

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

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.

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