Device Classification Name |
prosthesis, shoulder, non-constrained, metal/polymer cemented
|
510(k) Number |
K110791 |
Device Name |
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
ANTHONY FRANCALANCIA |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
ANTHONY FRANCALANCIA |
Regulation Number | 888.3650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/21/2011 |
Decision Date | 09/02/2011 |
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
|
|
|