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FDA 510(k), K113770, ORTHOFIX GALAXY FIXATION SYSTEM
FDA 510(k), K113770, ORTHOFIX GALAXY FIXATION SYSTEM
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510(K) Number: K113770
Device Name: ORTHOFIX GALAXY FIXATION SYSTEM
Manufacturer: ORTHOFIX SRL
Device Classification Name: appliance, fixation, nail/blade/plate combination, multiple component
Regulation Number: 888.3030
Classification Product Code: KTT
Date Received: 12/22/2011
Decision Date: 09/04/2012
Regulation Medical Specialty: Orthopedic
Device Name: ORTHOFIX GALAXY FIXATION SYSTEM
Manufacturer: ORTHOFIX SRL
Device Classification Name: appliance, fixation, nail/blade/plate combination, multiple component
Regulation Number: 888.3030
Classification Product Code: KTT
Date Received: 12/22/2011
Decision Date: 09/04/2012
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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