Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191247
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
More FDA Info for this Device
510(K) Number
K191247
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
TechMah Medical LLC
2099 Thunderhead Rd., Suite 302
Knoxville, TN 37922 US
Other 510(k) Applications for this Company
Contact
Mohamed R. Mahfouz
Other 510(k) Applications for this Contact
Regulation Number
888.3660
More FDA Info for this Regulation Number
Classification Product Code
KWS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/2019
Decision Date
11/15/2019
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