Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K161569 |
Device Name |
Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws |
Applicant |
Howmedica Osteonics Corp. aka Stryker Orthopaedics |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Valerie Giambanco |
Correspondent |
Howmedica Osteonics Corp. aka Stryker Orthopaedics |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Valerie Giambanco |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/07/2016 |
Decision Date | 10/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|