Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K934469 |
Device Name |
ARTHROTEK INTERFERENCE SCREW |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA SANDBORN BERES |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA SANDBORN BERES |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/10/1993 |
Decision Date | 02/23/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|