FDA 510(k) Application Details - K240212

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K240212
Device Name	Staple, Fixation, Bone
Applicant	Ortho Solutions UK Ltd. West Station Business Park, Spital Road, Unit 5 Maldon CM9 6FF GB Other 510(k) Applications for this Company
Contact	Alex Faley Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2024
Decision Date	02/23/2024
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