Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K240453 |
Device Name |
ReBOSSIS |
Applicant |
OrthoRebirth Co., Ltd. |
3-17-43 Chigasaki Higashi |
Yokohama,
JP
224-0033
|
|
Applicant Contact |
Yasutoshi Nishikawa |
Correspondent |
Mcra, LLC |
803 7th Street NW |
Washington,
DC
20001
|
|
Correspondent Contact |
Justin Eggleton |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 02/15/2024 |
Decision Date | 03/04/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|