The following data is part of a premarket notification filed by Protomed, Inc. with the FDA for Digiguide System.
| Device ID | K193499 |
| 510k Number | K193499 |
| Device Name: | DigiGuide System |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | ProtoMED, Inc. 1329 W 121st Ave Westminster, CO 80234 |
| Contact | James Jimenez |
| Correspondent | Rick Miller ProtoMED, Inc. 1329 W 121st Ave Westminster, CO 80234 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-11-04 |