Device Classification Name |
implant, endosseous, orthodontic
|
510(k) Number |
K113650 |
Device Name |
ORTHOFIX SCREW |
Applicant |
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC |
118 W. PRIVE CR. |
DELRAY TEZAK,
FL
33445
|
|
Applicant Contact |
JUAN TEZAK |
Correspondent |
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC |
118 W. PRIVE CR. |
DELRAY TEZAK,
FL
33445
|
|
Correspondent Contact |
JUAN TEZAK |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 12/12/2011 |
Decision Date | 10/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|