Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K181721 |
Device Name |
Ceracell Ortho Foam |
Applicant |
curasan AG |
Lindigstrasse 4 |
Kleinostheim,
DE
63801
|
|
Applicant Contact |
Gregor Thomas |
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 | 06/29/2018 |
Decision Date | 09/17/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|