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FDA 510(k), K162078, EVOS Small Fragment Plating System
FDA 510(k), K162078, EVOS Small Fragment Plating System
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510(K) Number: K162078
Device Name: EVOS Small Fragment Plating System
Manufacturer: SMITH & NEPHEW, INC.
Device Classification Name: plate, fixation, bone
Regulation Number: 888.3030
Classification Product Code: HRS
Date Received: 07/27/2016
Decision Date: 11/18/2016
Regulation Medical Specialty: Orthopedic
Device Name: EVOS Small Fragment Plating System
Manufacturer: SMITH & NEPHEW, INC.
Device Classification Name: plate, fixation, bone
Regulation Number: 888.3030
Classification Product Code: HRS
Date Received: 07/27/2016
Decision Date: 11/18/2016
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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