Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K101575 |
Device Name |
APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 |
Applicant |
OMNLIFE SCIENCE |
50 O'CONNELL WAY |
EAST TAUNTON,
MA
02718
|
|
Applicant Contact |
RADHIKA PONDICHERRY |
Correspondent |
OMNLIFE SCIENCE |
50 O'CONNELL WAY |
EAST TAUNTON,
MA
02718
|
|
Correspondent Contact |
RADHIKA PONDICHERRY |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 06/07/2010 |
Decision Date | 06/30/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|