Streamline TL Spinal Fixation System
K-Number: K192800 · 2020-01-14
Decision Date2020-01-14
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Streamline TL Spinal Fixation System is a medical device manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2020-01-14 under approval number K192800. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K192800.
When was Streamline TL Spinal Fixation System approved by the FDA?
Streamline TL Spinal Fixation System received FDA 510(k) clearance on 2020-01-14, under approval number K192800.
What company makes Streamline TL Spinal Fixation System?
Streamline TL Spinal Fixation System is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.).
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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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.