Device Classification Name |
Prosthesis, Elbow, Constrained, Cemented
|
510(k) Number |
K153398 |
Device Name |
Comprehensive SRS/Nexel Elbow |
Applicant |
BIOMET MANUFACTURING CORP. |
56 BELL DRIVE |
WARSAW,
IN
46580
|
|
Applicant Contact |
PATRICIA SANDBORN BERES |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 BELL DRIVE |
WARSAW,
IN
46580
|
|
Correspondent Contact |
PATRICIA SANDBORN BERES |
Regulation Number | 888.3150
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/24/2015 |
Decision Date | 02/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|