14 results
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62ms
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Sources: EU EUDAMED, US FDA
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Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 26, 2019
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·March 25, 2020
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·March 25, 2020
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·March 25, 2020
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·March 25, 2020
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
FDA Enforcement
Class II
·Terminated·Tedan Surgical Innovations Llc·September 26, 2012
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·July 15, 2020
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·July 15, 2020
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·July 15, 2020
PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·July 15, 2020
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·July 15, 2020
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·July 15, 2020
3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·July 15, 2020
Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.
FDA Enforcement
Class II
·Terminated·TeDan Surgical Innovations LLC·May 13, 2020