Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K013775 |
Device Name |
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM |
Applicant |
STRYKER LEIBINGER |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
ROBIN L ROWE |
Correspondent |
STRYKER LEIBINGER |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
ROBIN L ROWE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 11/13/2001 |
Decision Date | 01/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|