The following data is part of a premarket notification filed by Agnovos Healthcare Usa, Llc with the FDA for Jgh1 Bone Graft Substitute.
| Device ID | K181342 |
| 510k Number | K181342 |
| Device Name: | JGH1 Bone Graft Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | AgNovos Healthcare USA, LLC 7301 Calhoun Place, Suite 100 Rockville, MD 20855 |
| Contact | Felipe Aguel |
| Correspondent | Felipe Aguel AgNovos Healthcare USA, LLC 7301 Calhoun Place, Suite 100 Rockville, MD 20855 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-21 |
| Decision Date | 2018-07-19 |