Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component, metal composite
|
510(k) Number |
K941048 |
Device Name |
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR |
Applicant |
APPLIED OSTEO SYSTEMS, INC. |
1243 ALPINE RD. |
SUITE 221 |
WALNUT CREEK,
CA
94596 -4370
|
|
Applicant Contact |
SCOTT HUNTLEY |
Correspondent |
APPLIED OSTEO SYSTEMS, INC. |
1243 ALPINE RD. |
SUITE 221 |
WALNUT CREEK,
CA
94596 -4370
|
|
Correspondent Contact |
SCOTT HUNTLEY |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 03/07/1994 |
Decision Date | 10/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|