Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K220947
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K220947
Device Name
Washer, Bolt Nut
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
Other 510(k) Applications for this Company
Contact
Ivette Galmez
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
04/01/2022
Decision Date
06/06/2022
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