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FDA 510(k)

Streamline Navigated Instruments

K-Number: K200095 · 2020-06-26

ApplicantPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Decision Date2020-06-26
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Streamline Navigated Instruments 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 2020-06-26 under 510(k) number K200095. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Streamline Navigated Instruments?

Streamline Navigated Instruments is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K200095.

When did Streamline Navigated Instruments receive FDA 510(k) clearance?

Streamline Navigated Instruments received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200095.

Who is the listed applicant for Streamline Navigated Instruments?

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 Navigated Instruments?

The FDA product code for Streamline Navigated Instruments is OLO.

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Related Devices (Code: OLO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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