Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K083497 |
Device Name |
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS |
Applicant |
ZIMMER, INC. |
345 E. MAIN ST. |
WARSAW,
IN
46580
|
|
Applicant Contact |
CAROL VIERLING |
Correspondent |
ZIMMER, INC. |
345 E. MAIN ST. |
WARSAW,
IN
46580
|
|
Correspondent Contact |
CAROL VIERLING |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 11/25/2008 |
Decision Date | 02/19/2009 |
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
|
|
|