OsteoSinter® EVANS and COTTON wedges and related accessories— 510(k) K240461

Substantially Equivalent

Ames Medical Prosthetic Solutions, S.A.U.

FDA 510(k) clearance K240461 for OsteoSinter® EVANS and COTTON wedges and related accessories, Substantially Equivalent on 2024-12-06. Applicant: Ames Medical Prosthetic Solutions, S.A.U..

Clearance details

Applicant: Ames Medical Prosthetic Solutions, S.A.U.
Product code: Code PLF
Advisory panel: Orthopedic
Date received: 2024-02-16
Decision date: 2024-12-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sant Feliu De Llobregat, ES

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