Device Classification Name |
Orthosis, Spine, Plate, Laminoplasty, Metal
|
510(k) Number |
K121276 |
Device Name |
NEURO VENTION LAMINPLASTY PLATING SYSTEM |
Applicant |
NEUROVENTION LLC |
4628 NORTHPARK DRIVE |
MEREDITH MAY,
CO
80918
|
|
Applicant Contact |
MEREDITH MAY |
Correspondent |
NEUROVENTION LLC |
4628 NORTHPARK DRIVE |
MEREDITH MAY,
CO
80918
|
|
Correspondent Contact |
MEREDITH MAY |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 04/27/2012 |
Decision Date | 08/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|