Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K013490 |
Device Name |
CEMENTED CALCAR HIP SYSTEM |
Applicant |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Applicant Contact |
JOANNA DROEGE |
Correspondent |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
JOANNA DROEGE |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 10/22/2001 |
Decision Date | 01/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|