Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K993603 |
Device Name |
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW |
Applicant |
HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Applicant Contact |
JENNIFER A DAUDELIN |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Correspondent Contact |
JENNIFER A DAUDELIN |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 10/25/1999 |
Decision Date | 11/19/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|