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FDA 510(k), K192156, Cartiva SCI instrumentation set
FDA 510(k), K192156, Cartiva SCI instrumentation set
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510(K) Number: K192156
Device Name: Cartiva SCI instrumentation set
Manufacturer: Cartiva, Inc.
Device Classification Name: Instruments Designed For Press-Fit Osteochondral Implants
Regulation Number: 888.4505
Classification Product Code: QBO
Date Received: 08/09/2019
Decision Date: 09/04/2019
Regulation Medical Specialty: Orthopedic
Device Name: Cartiva SCI instrumentation set
Manufacturer: Cartiva, Inc.
Device Classification Name: Instruments Designed For Press-Fit Osteochondral Implants
Regulation Number: 888.4505
Classification Product Code: QBO
Date Received: 08/09/2019
Decision Date: 09/04/2019
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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