FDA 510(k)

Streamline OCT Occipito-Cervico-Thoracic System

Numéro K : K161498 · 2016-08-22

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

Date de décision2016-08-22

Code produitNKG

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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 2016-08-22 under 510(k) number K161498. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2016-08-22. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K161498.

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 2016-08-22, under 510(k) number K161498.

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.

Essais cliniques associés

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Dispositifs connexes (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.

Source officielle

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