QUANTUM® Patient Specific Instrumentation (PSI) System
K-Number: K211883 · 2021-08-11
ApplicantIn2bones Sas
Decision Date2021-08-11
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 2021-08-11 under approval number K211883. 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 2021-08-11. It is manufactured by In2bones Sas. The 510(k) number is K211883.
When was QUANTUM® Patient Specific Instrumentation (PSI) System approved by the FDA?
QUANTUM® Patient Specific Instrumentation (PSI) System received FDA 510(k) clearance on 2021-08-11, under approval number K211883.
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.