Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
|
510(k) Number |
K161155 |
Device Name |
Origin Coxa Vara Hip Stem |
Applicant |
SIGNATURE ORTHOPAEDICS PTY LTD. |
7 SIRIUS ROAD |
LANE COVE,
AU
2066
|
|
Applicant Contact |
Declan Brazil |
Correspondent |
SIGNATURE ORTHOPAEDICS PTY LTD. |
7 SIRIUS ROAD |
LANE COVE,
AU
2066
|
|
Correspondent Contact |
Declan Brazil |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/25/2016 |
Decision Date | 07/19/2016 |
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
|
|
|