Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K170339 |
Device Name |
Summit Hip System |
Applicant |
DePuy Orthopaedics, Inc. |
700 Orthopaedic Drive |
Warsaw,
IN
46582
|
|
Applicant Contact |
Carol S. Ming |
Correspondent |
DePuy Orthopaedics, Inc. |
700 Orthopaedic Drive |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Daniel J. Williman |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/02/2017 |
Decision Date | 04/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|