3D GraftRasp System
K-Number: K201900 · 2020-09-03
ApplicantSurgentec
Decision Date2020-09-03
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
3D GraftRasp System is a medical device manufactured by Surgentec. It received FDA 510(k) clearance on 2020-09-03 under approval number K201900. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 3D GraftRasp System?
3D GraftRasp System is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Surgentec. The 510(k) number is K201900.
When was 3D GraftRasp System approved by the FDA?
3D GraftRasp System received FDA 510(k) clearance on 2020-09-03, under approval number K201900.
What company makes 3D GraftRasp System?
3D GraftRasp System is manufactured by Surgentec.
What is the FDA product code for 3D GraftRasp System?
The FDA product code for 3D GraftRasp System is FMF.
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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.