Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K003077 |
Device Name |
SMARTSCREW MODEL 222006...227510 |
Applicant |
BIONX IMPLANTS, LTD. |
1777 SENTRY PARKWAY WEST |
BLUEBELL,
PA
19422
|
|
Applicant Contact |
GERARD S CARLOZZI |
Correspondent |
BIONX IMPLANTS, LTD. |
1777 SENTRY PARKWAY WEST |
BLUEBELL,
PA
19422
|
|
Correspondent Contact |
GERARD S CARLOZZI |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/03/2000 |
Decision Date | 04/26/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|