Device Classification Name |
intervertebral fusion device with bone graft, cervical
|
510(k) Number |
K192208 |
Device Name |
CORNICE Cervical Spacer System |
Applicant |
Legend Spine Technologies |
1803 Apple Tree Lane |
Bethlehem,
PA
18015
|
|
Applicant Contact |
Steve Marinelli |
Correspondent |
MRC-X, LLC |
6075 Poplar Ave |
Memphis,
TN
38119
|
|
Correspondent Contact |
Christine Scifert |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 08/14/2019 |
Decision Date | 10/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|