Materialise PKA Guide System
K-Number: K202207 · 2020-10-02
ApplicantMaterialise NV
Decision Date2020-10-02
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Materialise PKA Guide System is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2020-10-02 under approval number K202207. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Materialise PKA Guide System?
Materialise PKA Guide System is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Materialise NV. The 510(k) number is K202207.
When was Materialise PKA Guide System approved by the FDA?
Materialise PKA Guide System received FDA 510(k) clearance on 2020-10-02, under approval number K202207.
What company makes Materialise PKA Guide System?
Materialise PKA Guide System is manufactured by Materialise NV.
What is the FDA product code for Materialise PKA Guide System?
The FDA product code for Materialise PKA Guide System is HSX.
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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.