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FDA 510(k), K192863, MONDRIAN Lumbar Interbody Fusion Cage System
FDA 510(k), K192863, MONDRIAN Lumbar Interbody Fusion Cage System
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$149.00 USD
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510(K) Number: K192863
Device Name: MONDRIAN Lumbar Interbody Fusion Cage System
Manufacturer: CTL Medical Corporation
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 10/07/2019
Decision Date: 08/26/2020
Regulation Medical Specialty: Orthopedic
Device Name: MONDRIAN Lumbar Interbody Fusion Cage System
Manufacturer: CTL Medical Corporation
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 10/07/2019
Decision Date: 08/26/2020
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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