Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K931694 |
Device Name |
1/4 TUBULAR PLATE |
Applicant |
ONYX MEDICAL CORP. |
152 COLLINS ST. |
MEMPHIS,
TN
38112
|
|
Applicant Contact |
LARAINE B GILMORE |
Correspondent |
ONYX MEDICAL CORP. |
152 COLLINS ST. |
MEMPHIS,
TN
38112
|
|
Correspondent Contact |
LARAINE B GILMORE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/05/1993 |
Decision Date | 04/25/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|