FDA 510(k) Application Details - K242865

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal   More FDA Info for this Device
510(K) Number	K242865
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant	Biocomposites Ltd. Keele Science Park Keele ST5 5NL GB Other 510(k) Applications for this Company
Contact	Melisa Lamanna Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	KWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2024
Decision Date	06/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review