Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K942115 |
Device Name |
INFINITY REVISION HIP STEM |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
JUDY ENGLISH |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
JUDY ENGLISH |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/03/1994 |
Decision Date | 09/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|