The following data is part of a premarket notification filed by Orthorebirth Co., Ltd. with the FDA for Rebossis.
| Device ID | K142090 |
| 510k Number | K142090 |
| Device Name: | REBOSSIS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOREBIRTH CO., LTD. 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Contact | Kevin A.thomas |
| Correspondent | Kevin A.thomas ORTHOREBIRTH CO., LTD. 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 | 2014-08-01 |
| Decision Date | 2014-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04573190050231 | K142090 | 000 |
| 04573190050224 | K142090 | 000 |
| 04573190050132 | K142090 | 000 |
| 04573190050125 | K142090 | 000 |
| 04573190050118 | K142090 | 000 |
| 04573190050033 | K142090 | 000 |
| 04573190050026 | K142090 | 000 |
| 04573190050019 | K142090 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REBOSSIS 85602550 4564667 Live/Registered |
Orthorebirth Co., Ltd. 2012-04-19 |
![]() REBOSSIS 79232932 5694086 Live/Registered |
ORTHOREBIRTH CO., LTD. 2018-03-07 |