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FDA 510(k), K161447, HydroSet XT
FDA 510(k), K161447, HydroSet XT
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$149.00 USD
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$149.00 USD
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510(K) Number: K161447
Device Name: HydroSet XT
Manufacturer: ORTHOVITA, INC.
Device Classification Name: filler, bone void, calcium compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 05/25/2016
Decision Date: 10/06/2016
Regulation Medical Specialty: Orthopedic
Device Name: HydroSet XT
Manufacturer: ORTHOVITA, INC.
Device Classification Name: filler, bone void, calcium compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 05/25/2016
Decision Date: 10/06/2016
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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