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FDA 510(k), K123347, NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
FDA 510(k), K123347, NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
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510(K) Number: K123347
Device Name: NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
Manufacturer: DAVID C FURR
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: 10/31/2012
Date Received: 08/02/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
Manufacturer: DAVID C FURR
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: 10/31/2012
Date Received: 08/02/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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