Device Classification Name |
prosthesis, elbow, constrained, cemented
|
510(k) Number |
K150501 |
Device Name |
Zimmer Nexel Total Elbow Ulnar Cement Diverter |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46580 -0708
|
|
Applicant Contact |
Keith Proctor |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46580 -0708
|
|
Correspondent Contact |
Caroline Bloemker |
Regulation Number | 888.3150
|
Classification Product Code |
|
Date Received | 02/26/2015 |
Decision Date | 04/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|