22 results
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21ms
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Sources: EU EUDAMED, US FDA
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
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
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
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·May 1, 2019
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·February 5, 2020
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·August 5, 2020