Device Classification Name |
prosthesis, hip, femoral component, cemented, metal
|
510(k) Number |
K962002 |
Device Name |
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM |
Applicant |
EXACTECH, INC. |
4613 N.W. 6TH STREET, SUITE D |
GAINESVILLE,
FL
32609
|
|
Applicant Contact |
MARTHA C MILLER |
Correspondent |
EXACTECH, INC. |
4613 N.W. 6TH STREET, SUITE D |
GAINESVILLE,
FL
32609
|
|
Correspondent Contact |
MARTHA C MILLER |
Regulation Number | 888.3360
|
Classification Product Code |
|
Date Received | 05/22/1996 |
Decision Date | 08/08/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|