FDA 510(k), K132403, ANNEXTM ADJACENT LEVEL SYSTEM
FDA 510(k), K132403, ANNEXTM ADJACENT LEVEL SYSTEM
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510(K) Number: K132403
Device Name: ANNEXTM ADJACENT LEVEL SYSTEM
Manufacturer: SPINE WAVE, INC.
Device Classification Name: orthosis, spondylolisthesis spinal fixation
Regulation Number: 888.3070
Classification Product Code: MNH
Date Received: 08/01/2013
Decision Date: 01/10/2014
Regulation Medical Specialty: Orthopedic
Device Name: ANNEXTM ADJACENT LEVEL SYSTEM
Manufacturer: SPINE WAVE, INC.
Device Classification Name: orthosis, spondylolisthesis spinal fixation
Regulation Number: 888.3070
Classification Product Code: MNH
Date Received: 08/01/2013
Decision Date: 01/10/2014
Regulation Medical Specialty: Orthopedic