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FDA 510(k), K182114, FlareHawk Interbody Fusion System
FDA 510(k), K182114, FlareHawk Interbody Fusion System
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510(K) Number: K182114
Device Name: FlareHawk Interbody Fusion System
Manufacturer: Integrity Implants Inc
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 08/06/2018
Decision Date: 01/07/2019
Regulation Medical Specialty: Orthopedic
Device Name: FlareHawk Interbody Fusion System
Manufacturer: Integrity Implants Inc
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 08/06/2018
Decision Date: 01/07/2019
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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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