21 results · 14ms · Sources: EU EUDAMED, US FDA

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DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.

FDA Enforcement
Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·July 19, 2023

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·July 19, 2023

Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·July 19, 2023

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·July 19, 2023

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·July 19, 2023

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·July 19, 2023

Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.

FDA Enforcement
Class II ·Terminated·TITAN SPINE, LLC·August 12, 2015

Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·July 19, 2023

ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

FDA Enforcement
Class II ·Terminated·ulrich medical USA Inc·April 17, 2019

Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.

FDA Enforcement
Class II ·Terminated·Mazor Robotics Ltd·December 26, 2018

ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

FDA Enforcement
Class II ·Terminated·Aesculap, Inc.·July 31, 2013