FDA.reportPublic FDA data

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

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

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