Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K101451 |
FOIA Releasable 510(k) |
K101451
|
Device Name |
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD |
Applicant |
OMNI LIFE SCIENCE, INC. |
50 O'CONNELL WAY |
EAST TAUNTON,
MA
02718
|
|
Applicant Contact |
RADHIKA PONDICHERRY |
Correspondent |
OMNI LIFE SCIENCE, INC. |
50 O'CONNELL WAY |
EAST TAUNTON,
MA
02718
|
|
Correspondent Contact |
RADHIKA PONDICHERRY |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 05/25/2010 |
Decision Date | 06/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|