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FDA 510(k), K130380, ORTHOSENSOR KNEE BALANCER
FDA 510(k), K130380, ORTHOSENSOR KNEE BALANCER
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510(K) Number: K130380
Device Name: ORTHOSENSOR KNEE BALANCER
Manufacturer: ORTHOSENSOR, INC.
Device Classification Name: intraoperative orthopedic joint assessment aid
Regulation Number: 882.4560
Classification Product Code: ONN
Date Received: 02/14/2013
Decision Date: 06/13/2013
Regulation Medical Specialty: Neurology
Device Name: ORTHOSENSOR KNEE BALANCER
Manufacturer: ORTHOSENSOR, INC.
Device Classification Name: intraoperative orthopedic joint assessment aid
Regulation Number: 882.4560
Classification Product Code: ONN
Date Received: 02/14/2013
Decision Date: 06/13/2013
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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