| Device Classification Name |
Screw, Fixation, Bone
|
| 510(k) Number |
K110763 |
| Device Name |
LATARJET CORTICAL SCREW SET |
| Applicant |
| T.A.G. Medical Products Corporation, Ltd. |
| 291 Hillside Ave. |
|
Somerset,
MA
02726
|
|
| Applicant Contact |
GEORGE J HATTUB |
| Correspondent |
| T.A.G. Medical Products Corporation, Ltd. |
| 291 Hillside Ave. |
|
Somerset,
MA
02726
|
|
| Correspondent Contact |
GEORGE J HATTUB |
| Regulation Number | 888.3040 |
| Classification Product Code |
|
| Date Received | 03/18/2011 |
| Decision Date | 04/11/2011 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Summary |
Summary
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|