The following data is part of a premarket notification filed by Nanova Biomaterials Inc. with the FDA for Nanova Interference Screw.
| Device ID | K161174 |
| 510k Number | K161174 |
| Device Name: | Nanova Interference Screw |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | NANOVA BIOMATERIALS INC. 3806 MOJAVE CT Columbia, MO 65202 |
| Contact | Andrew Ritts |
| Correspondent | Andrew Ritts NANOVA BIOMATERIALS INC. 3806 MOJAVE CT Columbia, MO 65202 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-26 |
| Decision Date | 2016-11-03 |
| Summary: | summary |