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FDA 510(k), K150771, RxG Distraction System
FDA 510(k), K150771, RxG Distraction System
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$149.00 USD
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510(K) Number: K150771
Device Name: RxG Distraction System
Manufacturer: KLS MARTIN L.P.
Device Classification Name: cranial distraction system
Regulation Number: 882.5330
Classification Product Code: PBJ
Date Received: 03/24/2015
Decision Date: 08/27/2015
Regulation Medical Specialty: Neurology
Device Name: RxG Distraction System
Manufacturer: KLS MARTIN L.P.
Device Classification Name: cranial distraction system
Regulation Number: 882.5330
Classification Product Code: PBJ
Date Received: 03/24/2015
Decision Date: 08/27/2015
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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