Device Classification Name |
Prosthesis, Elbow, Constrained, Cemented
|
510(k) Number |
K181362 |
Device Name |
TEMA Elbow System |
Applicant |
Limacorporate S.p.A. |
via Nazionale 52 |
Villanova di San Daniele,
IT
33038
|
|
Applicant Contact |
Roberto Gabetta |
Correspondent |
Peoples & Associates Consulting LLC |
5010 Lodge Pole Lane |
Fort Wayne,
IN
46814
|
|
Correspondent Contact |
Stephen Peoples |
Regulation Number | 888.3150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/23/2018 |
Decision Date | 02/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|