Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K982598 |
Device Name |
OTI FEMORAL LOCK 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 |
|
Date Received | 07/24/1998 |
Decision Date | 10/02/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|