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FDA 510(k), K112484, ZAVATION SPINAL SYSTEM
FDA 510(k), K112484, ZAVATION SPINAL SYSTEM
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510(K) Number: K112484
Device Name: ZAVATION SPINAL SYSTEM
Manufacturer: ZAVATION LLC
Device Classification Name: orthosis, spinal pedicle fixation
Regulation Number: 888.3070
Classification Product Code: MNI
Date Received: 08/29/2011
Decision Date: 11/22/2011
Regulation Medical Specialty: Orthopedic
Device Name: ZAVATION SPINAL SYSTEM
Manufacturer: ZAVATION LLC
Device Classification Name: orthosis, spinal pedicle fixation
Regulation Number: 888.3070
Classification Product Code: MNI
Date Received: 08/29/2011
Decision Date: 11/22/2011
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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