Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K042249 |
Device Name |
CLS SPOTORNO STEM |
Applicant |
ZIMMER AUSTIN, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
AUDREY SWEARINGEN |
Correspondent |
ZIMMER AUSTIN, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
AUDREY SWEARINGEN |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 08/19/2004 |
Decision Date | 09/15/2004 |
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
|
|
|