Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
510(k) Number |
K964880 |
Device Name |
VARI-ANGLE HIP SCREW (VHS) SYSTEM |
Applicant |
WALTER ABENDSCHEIN, M.D. |
5530 WISCONSIN AVE. |
SUITE 705 |
CHEVY CHASE,
MD
20815
|
|
Applicant Contact |
WALTER ABENDSCHEIN |
Correspondent |
WALTER ABENDSCHEIN, M.D. |
5530 WISCONSIN AVE. |
SUITE 705 |
CHEVY CHASE,
MD
20815
|
|
Correspondent Contact |
WALTER ABENDSCHEIN |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 12/05/1996 |
Decision Date | 10/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|