FDA 510(k) Application Details - K233674

Device Classification Name	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained   More FDA Info for this Device
510(K) Number	K233674
Device Name	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Applicant	Ascension Orthopedics, Inc. 11101 Metric Blvd. Austin, TX 78758 US Other 510(k) Applications for this Company
Contact	Stephanie Rincones 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	11/16/2023
Decision Date	05/30/2024
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