The following data is part of a premarket notification filed by Orthorebirth Co., Ltd. with the FDA for Rebossis85.
Device ID | K172573 |
510k Number | K172573 |
Device Name: | ReBOSSIS85 |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | Orthorebirth Co., Ltd. 3-17-43 Chigasaki Higashi Tsuzuki-ku Yokohama, JP 224-0033 |
Contact | Yasutoshi Nishikawa |
Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-28 |
Decision Date | 2017-12-15 |
Summary: | summary |