MedCAD® AccuPlate® Patient-Specific Plate
Plate, Bone
MedCAD
The following data is part of a premarket notification filed by Medcad with the FDA for Medcad® Accuplate® Patient-specific Plate.
Pre-market Notification Details
| Device ID | K193280 |
| 510k Number | K193280 |
| Device Name: | MedCAD® AccuPlate® Patient-Specific Plate |
| Classification | Plate, Bone |
| Applicant | MedCAD 501 S 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 | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-27 |
| Decision Date | 2021-02-12 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810007630588 | K193280 | 000 |
| 00810007630946 | K193280 | 000 |
| 00810007630939 | K193280 | 000 |
| 00810007630922 | K193280 | 000 |
| 00810007630915 | K193280 | 000 |
| 00810007630908 | K193280 | 000 |
| 00810007630892 | K193280 | 000 |
| 00810007630885 | K193280 | 000 |
| 00810007630878 | K193280 | 000 |
| 00810007631097 | K193280 | 000 |
| 00810007631080 | K193280 | 000 |
| 00810007631509 | K193280 | 000 |
| 00810007631493 | K193280 | 000 |
| 00810007631486 | K193280 | 000 |
| 00810007631141 | K193280 | 000 |
| 00810007631134 | K193280 | 000 |
| 00810007630953 | K193280 | 000 |
| 00810007630960 | K193280 | 000 |
| 00810007630571 | K193280 | 000 |
| 00810007630564 | K193280 | 000 |
| 00810007630557 | K193280 | 000 |
| 00810007630540 | K193280 | 000 |
| 00810007630526 | K193280 | 000 |
| 00810007630519 | K193280 | 000 |
| 00810007630502 | K193280 | 000 |
| 00810007630496 | K193280 | 000 |
| 00810007630489 | K193280 | 000 |
| 00810007630472 | K193280 | 000 |
| 00810007630465 | K193280 | 000 |
| 00810007630458 | K193280 | 000 |
| 00810007630410 | K193280 | 000 |
| 00810007630984 | K193280 | 000 |
| 00810007630977 | K193280 | 000 |
| 00810007631127 | K193280 | 000 |
Trademark Results [MedCAD]
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 |
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