FDA 510(k) Application Details - K182171

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K182171
Device Name	Pin, Fixation, Threaded
Applicant	Summit MedVentures 7500 Rialto Blvd, Bldg 1, Ste 225 Austin, TX 78738 US Other 510(k) Applications for this Company
Contact	Nephi Zufelt Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2018
Decision Date	10/25/2018
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