Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K023022 |
Device Name |
NUGEN FX SCREW |
Applicant |
BIONX IMPLANTS, INC. |
1777 SENTRY PKWY. WEST, |
GWYNEDD HALL, SUITE 400 |
BLUE BELL,
PA
19422
|
|
Applicant Contact |
GERARD S CARLOZZI |
Correspondent |
BIONX IMPLANTS, INC. |
1777 SENTRY PKWY. WEST, |
GWYNEDD HALL, SUITE 400 |
BLUE BELL,
PA
19422
|
|
Correspondent Contact |
GERARD S CARLOZZI |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/11/2002 |
Decision Date | 10/04/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|