Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K212991 |
Device Name |
Osteorevive |
Applicant |
Bone Solutions, Inc. |
5712 Colleyville Boulevard, Suite 210 |
Colleyville,
TX
76034
|
|
Applicant Contact |
Drew Diaz |
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 |
|
Subsequent Product Code |
|
Date Received | 09/20/2021 |
Decision Date | 01/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|