The following data is part of a premarket notification filed by Ag Digital Technology Corp. with the FDA for A-grix Resorbable Bone Void Filler.
| Device ID | K091688 |
| 510k Number | K091688 |
| Device Name: | A-GRIX RESORBABLE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | AG DIGITAL TECHNOLOGY CORP. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich AG DIGITAL TECHNOLOGY CORP. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2010-03-02 |
| Summary: | summary |