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FDA 510(k), K081331, FIXXSURE CROSS LINK
FDA 510(k), K081331, FIXXSURE CROSS LINK
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510(K) Number: K081331
Device Name: FIXXSURE CROSS LINK
Manufacturer: SPINEWORKS, LLC
Device Classification Name: Orthosis, Spondylolisthesis Spinal Fixation
Regulation Number: 888.3070
Classification Product Code: MNH
Date Received: 05/12/2008
Decision Date: 07/23/2008
Regulation Medical Specialty: Orthopedic
Device Name: FIXXSURE CROSS LINK
Manufacturer: SPINEWORKS, LLC
Device Classification Name: Orthosis, Spondylolisthesis Spinal Fixation
Regulation Number: 888.3070
Classification Product Code: MNH
Date Received: 05/12/2008
Decision Date: 07/23/2008
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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