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FDA 510(k)

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

K-Number: K242865 · 2025-06-12

ApplicantBiocomposites, Ltd.
Decision Date2025-06-12
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer is a medical device manufactured by Biocomposites, Ltd.. It received FDA 510(k) clearance on 2025-06-12 under approval number K242865. 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 Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer?

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Biocomposites, Ltd.. The 510(k) number is K242865.

When was Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer approved by the FDA?

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer received FDA 510(k) clearance on 2025-06-12, under approval number K242865.

What company makes Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer?

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer is manufactured by Biocomposites, Ltd..

What is the FDA product code for Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer?

The FDA product code for Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer is KWL.

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Related Devices (Code: 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.

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