Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K082468 |
Device Name |
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) |
Applicant |
OMNI LIFE SCIENCE, INC. |
175 PARAMOUNT DRIVE |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
WILLIAM MCCALLUM |
Correspondent |
OMNI LIFE SCIENCE, INC. |
175 PARAMOUNT DRIVE |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
WILLIAM MCCALLUM |
Regulation Number | 888.3390
|
Classification Product Code |
|
Date Received | 08/27/2008 |
Decision Date | 02/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|