9 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 31, 2018
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
FDA Enforcement
Class II
·Completed·CTL Medical Corporation·July 15, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
FDA Enforcement
Class II
·Completed·CTL Medical Corporation·July 15, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
FDA Enforcement
Class II
·Completed·CTL Medical Corporation·July 15, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
FDA Enforcement
Class II
·Completed·CTL Medical Corporation·July 15, 2020
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
FDA Enforcement
Class II
·Terminated·CTL Medical Corporation·March 27, 2019
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
FDA Enforcement
Class II
·Terminated·CTL Medical Corporation·March 27, 2019
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Enforcement
Class II
·Terminated·MTI Precision Products LLC.·July 23, 2014
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
FDA Enforcement
Class II
·Ongoing·Spiggle & Theis Mt Gmbh·August 27, 2025