SI Screw System
K-Number: K173752 · 2018-03-16
ApplicantZavation Medical Products, LLC
Decision Date2018-03-16
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SI Screw System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2018-03-16 under approval number K173752. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SI Screw System?
SI Screw System is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K173752.
When was SI Screw System approved by the FDA?
SI Screw System received FDA 510(k) clearance on 2018-03-16, under approval number K173752.
What company makes SI Screw System?
SI Screw System is manufactured by Zavation Medical Products, LLC.
What is the FDA product code for SI Screw System?
The FDA product code for SI Screw System is OUR.
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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.