QUANTUM Patient Specific Instrumentation (PSI) System
K-Number: K230313 · 2023-04-06
ApplicantIn2bones Sas
Decision Date2023-04-06
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
QUANTUM Patient Specific Instrumentation (PSI) System is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2023-04-06 under approval number K230313. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the QUANTUM Patient Specific Instrumentation (PSI) System?
QUANTUM Patient Specific Instrumentation (PSI) System is a medical device that received FDA 510(k) clearance on 2023-04-06. It is manufactured by In2bones Sas. The 510(k) number is K230313.
When was QUANTUM Patient Specific Instrumentation (PSI) System approved by the FDA?
QUANTUM Patient Specific Instrumentation (PSI) System received FDA 510(k) clearance on 2023-04-06, under approval number K230313.
What company makes QUANTUM Patient Specific Instrumentation (PSI) System?
QUANTUM Patient Specific Instrumentation (PSI) System is manufactured by In2bones Sas.
What is the FDA product code for QUANTUM Patient Specific Instrumentation (PSI) System?
The FDA product code for QUANTUM Patient Specific Instrumentation (PSI) System is HSN.
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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.