FDA 510(k), K132733, ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
FDA 510(k), K132733, ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
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$149.00 USD
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510(K) Number: K132733
Device Name: ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
Manufacturer: ORTHOHELIX SURGICAL DESIGNS, INC.
Device Classification Name: washer, bolt nut
Regulation Number: 888.3030
Classification Product Code: HTN
Date Received: 09/03/2013
Decision Date: 01/03/2014
Regulation Medical Specialty: Orthopedic
Device Name: ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
Manufacturer: ORTHOHELIX SURGICAL DESIGNS, INC.
Device Classification Name: washer, bolt nut
Regulation Number: 888.3030
Classification Product Code: HTN
Date Received: 09/03/2013
Decision Date: 01/03/2014
Regulation Medical Specialty: Orthopedic