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FDA 510(k), K123045, BRIGADE STANDALONE SYSTEM
FDA 510(k), K123045, BRIGADE STANDALONE SYSTEM
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510(K) Number: K123045
Device Name: BRIGADE STANDALONE SYSTEM
Manufacturer: Cynthia Adams
Device Classification Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation Number: OVD
Classification Product Code: KXA
Date Received: 10/01/2012
Decision Date: 04/16/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: BRIGADE STANDALONE SYSTEM
Manufacturer: Cynthia Adams
Device Classification Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation Number: OVD
Classification Product Code: KXA
Date Received: 10/01/2012
Decision Date: 04/16/2013
Decision: Substantially Equivalent (SESE)
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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