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FDA 510(k)

OsteoSinter® EVANS and COTTON wedges and related accessories

K-Number: K240461 · 2024-12-06

ApplicantAmes Medical Prosthetic Solutions, S.A.U.
Decision Date2024-12-06
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoSinter® EVANS and COTTON wedges and related accessories is a medical device manufactured by Ames Medical Prosthetic Solutions, S.A.U.. It received FDA 510(k) clearance on 2024-12-06 under approval number K240461. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoSinter® EVANS and COTTON wedges and related accessories?

OsteoSinter® EVANS and COTTON wedges and related accessories is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Ames Medical Prosthetic Solutions, S.A.U.. The 510(k) number is K240461.

When was OsteoSinter® EVANS and COTTON wedges and related accessories approved by the FDA?

OsteoSinter® EVANS and COTTON wedges and related accessories received FDA 510(k) clearance on 2024-12-06, under approval number K240461.

What company makes OsteoSinter® EVANS and COTTON wedges and related accessories?

OsteoSinter® EVANS and COTTON wedges and related accessories is manufactured by Ames Medical Prosthetic Solutions, S.A.U..

What is the FDA product code for OsteoSinter® EVANS and COTTON wedges and related accessories?

The FDA product code for OsteoSinter® EVANS and COTTON wedges and related accessories is PLF.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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