FDA 510(k)

Streamline OCT Occipito-Cervico-Thoracic System

K-Nummer: K172139 · 2017-08-18

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

Entscheidungsdatum2017-08-18

ProduktcodeNKG

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Streamline OCT Occipito-Cervico-Thoracic 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 2017-08-18 under 510(k) number K172139. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Streamline OCT Occipito-Cervico-Thoracic System?

Streamline OCT Occipito-Cervico-Thoracic System is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K172139.

When did Streamline OCT Occipito-Cervico-Thoracic System receive FDA 510(k) clearance?

Streamline OCT Occipito-Cervico-Thoracic System received FDA 510(k) clearance on 2017-08-18, under 510(k) number K172139.

Who is the listed applicant for Streamline OCT Occipito-Cervico-Thoracic 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 OCT Occipito-Cervico-Thoracic System?

The FDA product code for Streamline OCT Occipito-Cervico-Thoracic System is NKG.

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Alle 13 Geräte anzeigen →

Verwandte Geräte (Code: NKG)

K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.

Offizielle Quelle

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