Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K994070 |
Device Name |
REVELATION 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 | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/02/1999 |
Decision Date | 01/20/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|