Intellihab System
K-Number: K210604 · 2021-06-03
ApplicantCymedica Orthopedics, Inc.
Decision Date2021-06-03
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Intellihab System is a medical device manufactured by Cymedica Orthopedics, Inc.. It received FDA 510(k) clearance on 2021-06-03 under approval number K210604. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Intellihab System?
Intellihab System is a medical device that received FDA 510(k) clearance on 2021-06-03. It is manufactured by Cymedica Orthopedics, Inc.. The 510(k) number is K210604.
When was Intellihab System approved by the FDA?
Intellihab System received FDA 510(k) clearance on 2021-06-03, under approval number K210604.
What company makes Intellihab System?
Intellihab System is manufactured by Cymedica Orthopedics, Inc..
What is the FDA product code for Intellihab System?
The FDA product code for Intellihab System is IPF.
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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.