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FDA 510(k), K191489, Genesys Spine 3DP Cervical Interbody System
FDA 510(k), K191489, Genesys Spine 3DP Cervical Interbody System
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510(K) Number: K191489
Device Name: Genesys Spine 3DP Cervical Interbody System
Manufacturer: Genesys Spine
Device Classification Name: intervertebral fusion device with integrated fixation, cervical
Regulation Number: 888.3080
Classification Product Code: OVE
Date Received: 06/04/2019
Decision Date: 01/08/2020
Regulation Medical Specialty: Orthopedic
Device Name: Genesys Spine 3DP Cervical Interbody System
Manufacturer: Genesys Spine
Device Classification Name: intervertebral fusion device with integrated fixation, cervical
Regulation Number: 888.3080
Classification Product Code: OVE
Date Received: 06/04/2019
Decision Date: 01/08/2020
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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