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FDA 510(k), K170650, Orthofix TrueLok Hexapod System (TL-HEX) V2.0
FDA 510(k), K170650, Orthofix TrueLok Hexapod System (TL-HEX) V2.0
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510(K) Number: K170650
Device Name: Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Manufacturer: Orthofix Srl
Device Classification Name: appliance, fixation, nail/blade/plate combination, multiple component
Regulation Number: 888.3030
Classification Product Code: KTT
Date Received: 03/03/2017
Decision Date: 05/10/2017
Regulation Medical Specialty: Orthopedic
Device Name: Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Manufacturer: Orthofix Srl
Device Classification Name: appliance, fixation, nail/blade/plate combination, multiple component
Regulation Number: 888.3030
Classification Product Code: KTT
Date Received: 03/03/2017
Decision Date: 05/10/2017
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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