Device Classification Name |
staple, fixation, bone
|
510(k) Number |
K041115 |
Device Name |
GII QUICKANCHOR PLUS |
Applicant |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
249 VANDERBILT AVE. |
NORWOOD,
MA
02062
|
|
Applicant Contact |
ALLYSON BARFORD |
Correspondent |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
249 VANDERBILT AVE. |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
ALLYSON BARFORD |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/29/2004 |
Decision Date | 05/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|