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FDA 510(k), K133482, SILC FIXATION SYSTEM
FDA 510(k), K133482, SILC FIXATION SYSTEM
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510(K) Number: K133482
Device Name: SILC FIXATION SYSTEM
Manufacturer: GLOBUS MEDICAL, INC.
Device Classification Name: bone fixation cerclage, sublaminar
Regulation Number: 888.3010
Classification Product Code: OWI
Date Received: 11/13/2013
Decision Date: 05/21/2014
Regulation Medical Specialty: Orthopedic
Device Name: SILC FIXATION SYSTEM
Manufacturer: GLOBUS MEDICAL, INC.
Device Classification Name: bone fixation cerclage, sublaminar
Regulation Number: 888.3010
Classification Product Code: OWI
Date Received: 11/13/2013
Decision Date: 05/21/2014
Regulation Medical Specialty: Orthopedic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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