FDA 510(k), K151462, SI-TECHNOLOGY® SI-DESIS® SCREWS
FDA 510(k), K151462, SI-TECHNOLOGY® SI-DESIS® SCREWS
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510(K) Number: K151462
Device Name: SI-TECHNOLOGY® SI-DESIS® SCREWS
Manufacturer: SI-TECHNOLOGY, LLC
Device Classification Name: sacroiliac joint fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 06/01/2015
Decision Date: 08/12/2015
Regulation Medical Specialty: Orthopedic
Device Name: SI-TECHNOLOGY® SI-DESIS® SCREWS
Manufacturer: SI-TECHNOLOGY, LLC
Device Classification Name: sacroiliac joint fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 06/01/2015
Decision Date: 08/12/2015
Regulation Medical Specialty: Orthopedic