The following data is part of a premarket notification filed by Orthorebirth Co., Ltd. with the FDA for Rebossis85.
| Device ID | K170620 |
| 510k Number | K170620 |
| 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 | 2017-03-01 |
| Decision Date | 2017-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04573190050354 | K170620 | 000 |
| 04573190050347 | K170620 | 000 |
| 04573190050330 | K170620 | 000 |
| 04573190050323 | K170620 | 000 |
| 04573190050316 | K170620 | 000 |
| 04573190050361 | K170620 | 000 |