FDA 510(k) Applications for Medical Device Product Code: PLF ()

FDA 510(k) Applications for Medical Device Product Code "PLF"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K191047	Additive Device, Inc. (ADI) d/b/a restor3d	ADI TiDAL Osteotomy Wedge	11/05/2019
K151256	Arthex, Inc	Arthrex BioSync« Bone Wedge	08/12/2015
K193414	Nvision Biomedical Technologies, Inc	Trigon HA Stand-Alone Wedge Fixation System	02/25/2020
K220197	Nvision Biomedical Technologies, Inc	Trigon HA Wedge Fixation System	02/23/2022
K203445	Nvision Biomedical Technologies, Inc.	Trigon HA Stand-Alone Wedge Fixation System	12/21/2020
K223226	Nvision Biomedical Technologies, Inc.	TrigonÖ HA Stand-Alone Wedge Fixation System	12/01/2022
K192645	Nvision Biomedical Technologies, Inc.	TrigonÖ Ti Stand-Alone Wedge Fixation System	12/23/2019
K162241	PARAGON 28	TITAN 3-DÖ Wedge System	04/03/2017
K231496	Paragon 28 Inc	TITAN 3-D Wedge System	08/22/2023
K201314	restor3d, Inc.	Restor3d Utility Wedge	06/17/2021
K171327	Tyber Medical LLC	Tyber Medical Wedge System	05/16/2017
K150394	TYBER MEDICAL LLC	Tyber Medical Wedge System	07/28/2015