Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K192236 |
Device Name |
Fitmore Hip Stem |
Applicant |
Zimmer GmbH |
Sulzer Allee 8 |
Winterthur,
CH
8404
|
|
Applicant Contact |
Roberto Tommasini |
Correspondent |
Zimmer GmbH |
Sulzer Allee 8 |
Winterthur,
CH
8404
|
|
Correspondent Contact |
Tobias Moller |
Regulation Number | 888.3390
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/19/2019 |
Decision Date | 11/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|