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FDA 510(k), K181295, Genesys Spine AIS-C Cervical Stand-Alone System
FDA 510(k), K181295, Genesys Spine AIS-C Cervical Stand-Alone System
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510(K) Number: K181295
Device Name: Genesys Spine AIS-C Cervical Stand-Alone System
Manufacturer: Genesys Spine
Device Classification Name: intervertebral fusion device with integrated fixation, cervical
Regulation Number: 888.3080
Classification Product Code: OVE
Date Received: 05/16/2018
Decision Date: 08/29/2018
Regulation Medical Specialty: Orthopedic
Device Name: Genesys Spine AIS-C Cervical Stand-Alone System
Manufacturer: Genesys Spine
Device Classification Name: intervertebral fusion device with integrated fixation, cervical
Regulation Number: 888.3080
Classification Product Code: OVE
Date Received: 05/16/2018
Decision Date: 08/29/2018
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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