Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K991226 |
Device Name |
FOUNDATION POROUS HIP STEM |
Applicant |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Applicant Contact |
DEBBIE DE LOS SANTOS |
Correspondent |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
DEBBIE DE LOS SANTOS |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/12/1999 |
Decision Date | 06/01/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|