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FDA 510(k), K201346, DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
FDA 510(k), K201346, DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
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510(K) Number: K201346
Device Name: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
Manufacturer: Synthes (USA) Products, LLC
Device Classification Name: Rod, Fixation, Intramedullary And Accessories
Regulation Number: 888.3020
Classification Product Code: HSB
Date Received: 05/21/2020
Decision Date: 09/23/2020
Regulation Medical Specialty: Orthopedic
Device Name: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
Manufacturer: Synthes (USA) Products, LLC
Device Classification Name: Rod, Fixation, Intramedullary And Accessories
Regulation Number: 888.3020
Classification Product Code: HSB
Date Received: 05/21/2020
Decision Date: 09/23/2020
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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