FDA 510(k) Application Details - K242833

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented   More FDA Info for this Device
510(K) Number	K242833
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant	Ortho Development Corp. 12187 S. Business Park Drive Draper, UT 84020 US Other 510(k) Applications for this Company
Contact	Drew Weaver Other 510(k) Applications for this Contact
Regulation Number	888.3358   More FDA Info for this Regulation Number
Classification Product Code	LPH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2024
Decision Date	10/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review