DYNAMIS SI Screw System
K-Number: K243565 · 2025-02-28
ApplicantPromethean Restorative, LLC
Decision Date2025-02-28
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
DYNAMIS SI Screw System is a medical device manufactured by Promethean Restorative, LLC. It received FDA 510(k) clearance on 2025-02-28 under approval number K243565. 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 DYNAMIS SI Screw System?
DYNAMIS SI Screw System is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Promethean Restorative, LLC. The 510(k) number is K243565.
When was DYNAMIS SI Screw System approved by the FDA?
DYNAMIS SI Screw System received FDA 510(k) clearance on 2025-02-28, under approval number K243565.
What company makes DYNAMIS SI Screw System?
DYNAMIS SI Screw System is manufactured by Promethean Restorative, LLC.
What is the FDA product code for DYNAMIS SI Screw System?
The FDA product code for DYNAMIS 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.