FDA 510(k) Application Details - K233531

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K233531
Device Name	Washer, Bolt Nut
Applicant	Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 US Other 510(k) Applications for this Company
Contact	Douglas Fulton Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2023
Decision Date	02/02/2024
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