Ion Facet Screw System
K-Number: K211855 · 2022-02-25
Device Summary
Frequently Asked Questions
What is the Ion Facet Screw System?
Ion Facet Screw System is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is SurGenTec, LLC. The 510(k) number is K211855.
When did Ion Facet Screw System receive FDA 510(k) clearance?
Ion Facet Screw System received FDA 510(k) clearance on 2022-02-25, under 510(k) number K211855.
Who is the listed applicant for Ion Facet Screw System?
The FDA 510(k) record lists SurGenTec, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ion Facet Screw System?
The FDA product code for Ion Facet Screw System is MRW.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing SurGenTec, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MRW)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.