FDA 510(k) Application Details - K231447

Device Classification Name	More FDA Info for this Device
510(K) Number	K231447
Device Name	Double Internal Joint Stabilizer- Elbow
Applicant	Skeletal Dynamics Inc 7300 North Kendall Drive Miami, FL 33156 US Other 510(k) Applications for this Company
Contact	Alexandra Rodriguez Rojas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2023
Decision Date	12/15/2023
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