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FDA 510(k), K141953, ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
FDA 510(k), K141953, ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
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510(K) Number: K141953
Device Name: ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
Manufacturer: TITAN SPINE, LLC
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 07/18/2014
Decision Date: 10/27/2014
Regulation Medical Specialty: Orthopedic
Device Name: ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
Manufacturer: TITAN SPINE, LLC
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 07/18/2014
Decision Date: 10/27/2014
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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