Device Classification Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
|
510(k) Number |
K122773 |
Device Name |
CROSS-OVER ACETABULAR SHELL & LINER |
Applicant |
STELKAST COMPANY |
200 HIDDEN VALLEY RD. |
MCMURRAY,
PA
15317
|
|
Applicant Contact |
DAVID STUMPO |
Correspondent |
STELKAST COMPANY |
200 HIDDEN VALLEY RD. |
MCMURRAY,
PA
15317
|
|
Correspondent Contact |
DAVID STUMPO |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/10/2012 |
Decision Date | 10/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|