Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K091973 |
Device Name |
METASUL TAPER LINERS, METASUL FEMORAL HEADS |
Applicant |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
BENJAMIN C CURSON |
Correspondent |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
BENJAMIN C CURSON |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 07/01/2009 |
Decision Date | 11/17/2009 |
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
|
|
|