Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K050882 |
Device Name |
NEWDEAL ANKLE NAIL |
Applicant |
NEWDEAL S.A. |
311 ENTERPRISE DRIVE |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
JUDITH E O'GRADY |
Correspondent |
NEWDEAL S.A. |
311 ENTERPRISE DRIVE |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
JUDITH E O'GRADY |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 04/07/2005 |
Decision Date | 05/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|