Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K011262 |
Device Name |
MODIFICATION TO THE BOLD SCREW |
Applicant |
NEWDEAL S.A. |
9109 COPENHAVER DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
NORMAN F ESTRIN |
Correspondent |
NEWDEAL S.A. |
9109 COPENHAVER DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
NORMAN F ESTRIN |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 04/25/2001 |
Decision Date | 06/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|