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510(k) K191047

Device
ADI TiDAL Osteotomy Wedge
Applicant
Additive Device, Inc. (ADI) D/b/a Restor3d
510(k) number
K191047
Product code
PLF  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-05
Date received
2019-04-19
Regulation
888.3030
Classification name
Bone Wedge
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nathan Evans
Address
311 W. Corporation St. Durham NC US 27701 27701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC2026-02-19
K252254Osteotomy Wedge SystemSinaptic Surgical2025-10-17
K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC2025-09-25
K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.2024-12-06
K243231Trigon PEEK HA WedgesNvision Biomedical Technologies2024-11-08
K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies2024-01-26
K231496TITAN 3-D Wedge SystemParagon 28, Inc.2023-08-22
K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2022-12-01
K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.2022-02-23
K201314Restor3d Utility WedgeRestor3D, Inc.2021-06-17
K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2020-12-21
K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2020-02-25
K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2019-12-23
K171327Tyber Medical Wedge SystemTyber Medical, LLC2017-05-16
K162241TITAN 3-D™ Wedge SystemParagon 282017-04-03

Legacy Summary#

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FDA Review#

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