FDA 510(k) Application Details - K222244

Device Classification Name Plate, Fixation, Bone

  More FDA Info for this Device
510(K) Number K222244
Device Name Plate, Fixation, Bone
Applicant Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
Other 510(k) Applications for this Company
Contact Stacy Valdez
Other 510(k) Applications for this Contact
Regulation Number 888.3030

  More FDA Info for this Regulation Number
Classification Product Code HRS
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/26/2022
Decision Date 09/30/2022
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