FDA 510(k)

Streamline TL Spinal Fixation System

Numéro K : K192800 · 2020-01-14

DemandeurPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Date de décision2020-01-14

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Streamline TL Spinal Fixation System 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 2020-01-14 under 510(k) number K192800. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Streamline TL Spinal Fixation System?

Streamline TL Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K192800.

When did Streamline TL Spinal Fixation System receive FDA 510(k) clearance?

Streamline TL Spinal Fixation System received FDA 510(k) clearance on 2020-01-14, under 510(k) number K192800.

Who is the listed applicant for Streamline TL Spinal Fixation System?

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 Streamline TL Spinal Fixation System?

The FDA product code for Streamline TL Spinal Fixation System is NKB.

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Dispositifs connexes (Code : NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Source officielle

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