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FDA 510(k), K162567, ExactechGPS Total Shoulder Application, Equinoxe Planning Software
FDA 510(k), K162567, ExactechGPS Total Shoulder Application, Equinoxe Planning Software
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510(K) Number: K162567
Device Name: ExactechGPS Total Shoulder Application, Equinoxe Planning Software
Manufacturer: Blue Ortho
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 09/14/2016
Decision Date: 04/05/2017
Regulation Medical Specialty: Neurology
Device Name: ExactechGPS Total Shoulder Application, Equinoxe Planning Software
Manufacturer: Blue Ortho
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 09/14/2016
Decision Date: 04/05/2017
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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