5 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·November 21, 2018
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·January 23, 2019
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·November 7, 2018
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·July 28, 2021
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·December 14, 2022