The following data is part of a premarket notification filed by Ag Digital Technology Corp. with the FDA for A-grix Te Resorable Bone Void Filler.
| Device ID | K121453 |
| 510k Number | K121453 |
| Device Name: | A-GRIX TE RESORABLE 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 | 2012-05-16 |
| Decision Date | 2013-02-05 |
| Summary: | summary |