Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K052614 |
Device Name |
LOW PROFILE PLATE AND SCREW SYSTEM |
Applicant |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Applicant Contact |
SALLY FOUST |
Correspondent |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Correspondent Contact |
SALLY FOUST |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/23/2005 |
Decision Date | 09/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|