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FDA 510(k), K121765, SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
FDA 510(k), K121765, SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
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510(K) Number: K121765
Device Name: SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
Manufacturer: STANMORE IMPLANTS WORLDWIDE LTD
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 06/15/2012
Decision Date: 01/11/2013
Regulation Medical Specialty: Neurology
Device Name: SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
Manufacturer: STANMORE IMPLANTS WORLDWIDE LTD
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 06/15/2012
Decision Date: 01/11/2013
Regulation Medical Specialty: Neurology
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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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