Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K172467 |
Device Name |
OMNI ARC Anteverted Neck Hip Stem |
Applicant |
OMNIlife science |
480 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
Christina Rovaldi |
Correspondent |
OMNIlife science |
480 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Christina Rovaldi |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 08/15/2017 |
Decision Date | 12/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|