Device Classification Name |
Plate, Bone
|
510(k) Number |
K071612 |
Device Name |
MODUS TRILOCK 2.0/2.3/2.5 |
Applicant |
MEDARTIS AG |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
LINDA SCHULZ |
Correspondent |
MEDARTIS AG |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LINDA SCHULZ |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 06/13/2007 |
Decision Date | 09/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|