Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K172573 |
Device Name |
ReBOSSIS85 |
Applicant |
Orthorebirth Co., Ltd. |
3-17-43 Chigasaki Higashi |
Tsuzuki-ku Yokohama,
JP
224-0033
|
|
Applicant Contact |
Yasutoshi Nishikawa |
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 | 08/28/2017 |
Decision Date | 12/15/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|