FDA 510(k) Application Details - K242442

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K242442
Device Name	Screw, Fixation, Bone
Applicant	Innovate Orthopaedics Ltd The Globe Bridge Street Slaithwaite, Huddersfield HD7 5JN GB Other 510(k) Applications for this Company
Contact	Mike Bilson Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2024
Decision Date	01/31/2025
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