Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K930156 |
Device Name |
MEGA PLUS SUPER LAG SCREW |
Applicant |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
ROBERT E SMITH |
Correspondent |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
ROBERT E SMITH |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 01/13/1993 |
Decision Date | 02/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|