Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K011102 |
Device Name |
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM |
Applicant |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
LISA M MILLINGTON |
Correspondent |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
LISA M MILLINGTON |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 04/11/2001 |
Decision Date | 08/03/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|