Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K162087 |
Device Name |
NovoGro |
Applicant |
OsteoNovus, Inc. |
1510 North Westwood Avenue, Suite 1080 |
Toledo,
OH
43606
|
|
Applicant Contact |
Brian M. Schlossberg |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Kevin A. Thomas |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 07/28/2016 |
Decision Date | 04/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|