OsteoRemedies Hip Spacer System
K-Number: K253675 · 2025-12-23
ApplicantOsteoremedies, LLC
Decision Date2025-12-23
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OsteoRemedies Hip Spacer System is a medical device manufactured by Osteoremedies, LLC. It received FDA 510(k) clearance on 2025-12-23 under approval number K253675. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OsteoRemedies Hip Spacer System?
OsteoRemedies Hip Spacer System is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Osteoremedies, LLC. The 510(k) number is K253675.
When was OsteoRemedies Hip Spacer System approved by the FDA?
OsteoRemedies Hip Spacer System received FDA 510(k) clearance on 2025-12-23, under approval number K253675.
What company makes OsteoRemedies Hip Spacer System?
OsteoRemedies Hip Spacer System is manufactured by Osteoremedies, LLC.
What is the FDA product code for OsteoRemedies Hip Spacer System?
The FDA product code for OsteoRemedies Hip Spacer System is KWL.
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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.