FDA 510(k) Application Details - K203105

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K203105
Device Name	Screw, Fixation, Bone
Applicant	Inion Oy Laakarinkatu 2 Tampere 33520 FI Other 510(k) Applications for this Company
Contact	Kati Marttinen 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	10/15/2020
Decision Date	01/13/2021
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