FDA 510(k) Application Details - K220650

Device Classification Name Washer, Bolt Nut

  More FDA Info for this Device
510(K) Number K220650
Device Name Washer, Bolt Nut
Applicant TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita, CA 91355 US
Other 510(k) Applications for this Company
Contact David Medoff
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 03/07/2022
Decision Date 06/01/2022
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact