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510(k) K242865

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer by Biocomposites, Ltd. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2025
Date Received
September 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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