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FDA 510(k), K181749, SuperCable® Iso-Elastic™ Cerclage System
FDA 510(k), K181749, SuperCable® Iso-Elastic™ Cerclage System
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510(K) Number: K181749
Device Name: SuperCable® Iso-Elastic™ Cerclage System
Manufacturer: Kinamed, Incorporated
Device Classification Name: cerclage, fixation
Regulation Number: 888.3010
Classification Product Code: JDQ
Date Received: 07/02/2018
Decision Date: 08/01/2018
Regulation Medical Specialty: Orthopedic
Device Name: SuperCable® Iso-Elastic™ Cerclage System
Manufacturer: Kinamed, Incorporated
Device Classification Name: cerclage, fixation
Regulation Number: 888.3010
Classification Product Code: JDQ
Date Received: 07/02/2018
Decision Date: 08/01/2018
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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