Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K021822 |
Device Name |
R120 MODULAR TOTAL HIP SYSTEM |
Applicant |
OSTEOIMPLANT TECHNOLOGY, INC. |
11201 PEPPER RD. |
HUNT VALLEY,
MD
21031 -1201
|
|
Applicant Contact |
SAM SON |
Correspondent |
OSTEOIMPLANT TECHNOLOGY, INC. |
11201 PEPPER RD. |
HUNT VALLEY,
MD
21031 -1201
|
|
Correspondent Contact |
SAM SON |
Regulation Number | 888.3350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/04/2002 |
Decision Date | 07/23/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|