Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
|
510(k) Number |
K211703 |
Device Name |
Insignia Hip Stem |
Applicant |
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 |
Gregg Ritter |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/03/2021 |
Decision Date | 08/16/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|