Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K130099 |
Device Name |
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 |
Applicant |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Applicant Contact |
WILLIAM GARZON |
Correspondent |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
WILLIAM GARZON |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/15/2013 |
Decision Date | 06/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|