Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190599
Device Classification Name
Prosthesis, Wrist, Hemi-, Ulnar
More FDA Info for this Device
510(K) Number
K190599
Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Applicant
Aptis Medical, LLC
3602 Glenview Ave.
Glenview, KY 40025 US
Other 510(k) Applications for this Company
Contact
Bryan Babb
Other 510(k) Applications for this Contact
Regulation Number
888.3810
More FDA Info for this Regulation Number
Classification Product Code
KXE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/08/2019
Decision Date
05/03/2019
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