Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K130899 |
FOIA Releasable 510(k) |
K130899
|
Device Name |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
Applicant |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
REBECCA M BROOKS |
Correspondent |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
REBECCA M BROOKS |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 04/01/2013 |
Decision Date | 05/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|