FDA 510(k) Application Details - K243381

Device Classification Name	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained   More FDA Info for this Device
510(K) Number	K243381
Device Name	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Applicant	Skeletal Dynamics Inc 7300 N Kendall Dr Miami, FL 33156 US Other 510(k) Applications for this Company
Contact	Alexandra Rodriguez Other 510(k) Applications for this Contact
Regulation Number	888.3800   More FDA Info for this Regulation Number
Classification Product Code	JWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2024
Decision Date	11/01/2024
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