FDA.report

510(k) K240461

Device
OsteoSinter® EVANS and COTTON wedges and related accessories
Applicant
Ames Medical Prosthetic Solutions, S.A.U.
510(k) number
K240461
Product code
PLF
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-06
Date received
2024-02-16
Regulation
888.3030
Classification name
Bone Wedge
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Emili Tarrats
Address
Ctra. Laurea Miro 388 Sant Feliu De Llobregat ES 08980 08980

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08437019951504OsteoSinter® EVANS wedge 20W x 20L x 10H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951412OsteoSinter® EVANS wedge 18W x 18L x 6HAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951429OsteoSinter® EVANS wedge 20Wx20Lx6HAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951436OsteoSinter® EVANS wedge 22W x 22L x 6HAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951443Single-use OsteoSinter® EVANS instrument kitAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951450Single-use OsteoSinter® COTTON instrument kitAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951467OsteoSinter® EVANS wedge 18W x 18L x 8H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951474OsteoSinter® EVANS wedge 18W x 18L x 10H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951481OsteoSinter® EVANS wedge 18W x 18L x 12H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951498OsteoSinter® EVANS wedge 20W x 20L x 8H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951603OsteoSinter® COTTON wedge 20L x 6.5H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951511OsteoSinter® EVANS wedge 20W x 20L x 12H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951528OsteoSinter® EVANS wedge 22W x 22L x 8H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951535OsteoSinter® EVANS wedge 22W x 22L x 10H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951542OsteoSinter® EVANS wedge 22W x 22L x 12H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951559OsteoSinter® COTTON wedge 15L x 4.5H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951566OsteoSinter® COTTON wedge 15L x 5.5H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951573OsteoSinter® COTTON wedge 15L x 6.5H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951580OsteoSinter® COTTON wedge 20L x 4.5H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14
08437019951597OsteoSinter® COTTON wedge 20L x 5.5H mmAMES MEDICAL PROSTHETIC SOLUTIONS S.A.2025-03-14

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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
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