16 results
·
59ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·November 14, 2012
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·January 25, 2017
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·December 27, 2017
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·June 15, 2022
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·February 13, 2013
Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for cementless use in total hip arthroplasty.
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·March 6, 2013
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·July 12, 2017
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·October 31, 2018
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·January 15, 2020
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·December 14, 2022
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
FDA Enforcement
Class II
·Completed·Medacta Usa Inc·April 26, 2023
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
FDA Enforcement
Class II
·Completed·Medacta Usa Inc·April 26, 2023
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
FDA Enforcement
Class II
·Completed·Medacta Usa Inc·April 26, 2023
MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
FDA Enforcement
Class II
·Completed·Medacta Usa Inc·April 26, 2023
MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
FDA Enforcement
Class II
·Completed·Medacta Usa Inc·April 26, 2023
MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
FDA Enforcement
Class II
·Completed·Medacta Usa Inc·April 26, 2023