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FDA 510(k), K191412, VariAx 2 System, VariAx 2 Mini Fragment System
FDA 510(k), K191412, VariAx 2 System, VariAx 2 Mini Fragment System
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$149.00 USD
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$149.00 USD
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510(K) Number: K191412
Device Name: VariAx 2 System, VariAx 2 Mini Fragment System
Manufacturer: Stryker GmbH
Device Classification Name: Plate, Fixation, Bone
Regulation Number: 888.3030
Classification Product Code: HRS
Date Received: 05/28/2019
Decision Date: 08/23/2019
Regulation Medical Specialty: Orthopedic
Device Name: VariAx 2 System, VariAx 2 Mini Fragment System
Manufacturer: Stryker GmbH
Device Classification Name: Plate, Fixation, Bone
Regulation Number: 888.3030
Classification Product Code: HRS
Date Received: 05/28/2019
Decision Date: 08/23/2019
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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