Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K042244 |
Device Name |
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE |
Applicant |
TRIAGE MEDICAL, INC. |
13700 ALTON PKWY., SUITE 160 |
IRVINE,
CA
92618
|
|
Applicant Contact |
GAYLE HIROTA |
Correspondent |
TRIAGE MEDICAL, INC. |
13700 ALTON PKWY., SUITE 160 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
GAYLE HIROTA |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 08/19/2004 |
Decision Date | 09/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|