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FDA 510(k), K110123, PCL TIGHTROPE
FDA 510(k), K110123, PCL TIGHTROPE
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510(K) Number: K110123
Device Name: PCL TIGHTROPE
Manufacturer: COURTNEY SMITH
Device Classification Name: Pin, Fixation, Smooth
Regulation Number: HTY
Classification Product Code: KXA
Date Received: 01/18/2011
Decision Date: 04/28/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: PCL TIGHTROPE
Manufacturer: COURTNEY SMITH
Device Classification Name: Pin, Fixation, Smooth
Regulation Number: HTY
Classification Product Code: KXA
Date Received: 01/18/2011
Decision Date: 04/28/2011
Decision: Substantially Equivalent (SESE)
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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