The following data is part of a premarket notification filed by Medcad with the FDA for Medcad® Accuplan® System.
| Device ID | K192282 |
| 510k Number | K192282 |
| Device Name: | MedCAD® AccuPlan® System |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | MedCAD 501 2nd Ave, Suite A-1000 Dallas, TX 75226 |
| Contact | Brian Buss |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2020-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810007630533 | K192282 | 000 |
| 00810007630281 | K192282 | 000 |
| 00810007630274 | K192282 | 000 |
| 00810007630267 | K192282 | 000 |
| 00810007630250 | K192282 | 000 |
| 00810007630243 | K192282 | 000 |
| 00810007630236 | K192282 | 000 |
| 00810007630229 | K192282 | 000 |
| 00810007630212 | K192282 | 000 |
| 00810007630205 | K192282 | 000 |
| 00810007630298 | K192282 | 000 |
| 00810007630304 | K192282 | 000 |
| 00810007630441 | K192282 | 000 |
| 00810007630427 | K192282 | 000 |
| 00810007630373 | K192282 | 000 |
| 00810007630366 | K192282 | 000 |
| 00810007630359 | K192282 | 000 |
| 00810007630342 | K192282 | 000 |
| 00810007630335 | K192282 | 000 |
| 00810007630328 | K192282 | 000 |
| 00810007630311 | K192282 | 000 |
| 00810007630199 | K192282 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEDCAD 87827361 5687821 Live/Registered |
Vanduzen, Inc 2018-03-09 |
![]() MEDCAD 78841748 3332287 Dead/Cancelled |
VanDuzen, Inc. 2006-03-20 |