Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K170072 |
Device Name |
Fitmore® Hip Stem |
Applicant |
Zimmer GmbH |
Sulzerallee 8 |
Winterthur,
CH
8404
|
|
Applicant Contact |
Thomas Lincoln |
Correspondent |
Zimmer GmbH |
Sulzerallee 8 |
Winterthur,
CH
8404
|
|
Correspondent Contact |
Thomas Lincoln |
Regulation Number | 888.3390
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/09/2017 |
Decision Date | 02/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|