27 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·November 22, 2017
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
BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·June 22, 2016
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 25, 2020
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
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·June 22, 2016
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·June 22, 2016
BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·June 22, 2016
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·June 22, 2016
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·June 22, 2016
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·April 7, 2021
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·April 20, 2016
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·May 17, 2017
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016
Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·May 17, 2017
Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·May 17, 2017
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·May 17, 2017
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·May 17, 2017
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·May 17, 2017
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