FDA.reportPublic FDA data

510(k) K252254

Device
Osteotomy Wedge System
Applicant
Sinaptic Surgical
510(k) number
K252254
Product code
PLF
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-17
Date received
2025-07-21
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
N

Applicant Contact#

Contact
Brian Hockett
Address
1885 W. 2100 S. Slat Lake City UT US 84119 84119

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLF#

510(k), Device, Applicant table
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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
K191047ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D2019-11-05
K171327Tyber Medical Wedge SystemTyber Medical, LLC2017-05-16
K162241TITAN 3-D™ Wedge SystemParagon 282017-04-03