CyMedica e-vive System; CY-1000
K-Number: K163067 · 2016-12-01
ApplicantCymedica Orthopedics, Inc.
Decision Date2016-12-01
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
CyMedica e-vive System; CY-1000 is a medical device manufactured by Cymedica Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-12-01 under approval number K163067. 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 CyMedica e-vive System; CY-1000?
CyMedica e-vive System; CY-1000 is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Cymedica Orthopedics, Inc.. The 510(k) number is K163067.
When was CyMedica e-vive System; CY-1000 approved by the FDA?
CyMedica e-vive System; CY-1000 received FDA 510(k) clearance on 2016-12-01, under approval number K163067.
What company makes CyMedica e-vive System; CY-1000?
CyMedica e-vive System; CY-1000 is manufactured by Cymedica Orthopedics, Inc..
What is the FDA product code for CyMedica e-vive System; CY-1000?
The FDA product code for CyMedica e-vive System; CY-1000 is IPF.
Other Devices by Cymedica Orthopedics, Inc.
Related Devices (Code: IPF)
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.