8 results
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6ms
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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
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
FDA Enforcement
Class II
·Terminated·KT Health, LLC·April 29, 2020