Device Classification Name |
prosthesis, elbow, constrained, cemented
|
510(k) Number |
K123862 |
FOIA Releasable 510(k) |
K123862
|
Device Name |
ZIMMER NEXEL TOTAL ELBOW |
Applicant |
ZIMMER, INC. |
1800 WEST CENTER STREET |
WARSAW,
IN
46580
|
|
Applicant Contact |
JOANNA L SURMA |
Correspondent |
ZIMMER, INC. |
1800 WEST CENTER STREET |
WARSAW,
IN
46580
|
|
Correspondent Contact |
JOANNA L SURMA |
Regulation Number | 888.3150
|
Classification Product Code |
|
Date Received | 12/14/2012 |
Decision Date | 03/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|