Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K163086 |
Device Name |
VLP MINI-MOD 2.0mm Column Plates |
Applicant |
SMITH & NEPHEW, INC. |
1450 BROOKS RD |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
SAMANTHA STAUBACH |
Correspondent |
SMITH & NEPHEW, INC. |
1450 BROOKS RD |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
SAMANTHA STAUBACH |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 11/03/2016 |
Decision Date | 12/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|