FDA 510(k) Application Details - K220190

Device Classification Name	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis   More FDA Info for this Device
510(K) Number	K220190
Device Name	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Applicant	Pega Medical, Inc. 1111 Autoroute Chomedey Laval H7W 5J8 CA Other 510(k) Applications for this Company
Contact	Ariel R. Dujovne Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	OBT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2022
Decision Date	10/24/2022
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