FDA 510(k) Application Details - K243839

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate   More FDA Info for this Device
510(K) Number	K243839
Device Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant	Exactech, Inc. 2320 NW 66th Ct. Gainesville, FL 32653 US Other 510(k) Applications for this Company
Contact	Pedro Ravelo Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	MEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2024
Decision Date	03/10/2025
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