AccuPlate MC-PLT010
GUDID 00810007630557
MANDIBLE, 2.6 HEMI
Medcad
Craniofacial fixation plate, non-bioabsorbable| Primary Device ID | 00810007630557 |
| NIH Device Record Key | 93db064f-3ef2-49f7-b0bd-c2489809f760 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuPlate |
| Version Model Number | MC-PLT010 |
| Catalog Number | MC-PLT010 |
| Company DUNS | 144723868 |
| Company Name | Medcad |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810007630557 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193280
FDA Product Code
| JEY | Plate, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
[00810007630557]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-22 |
| Device Publish Date | 2021-09-14 |
On-Brand Devices [AccuPlate]
| 00810007630588 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT BUNDLED WITH ACCUPLATE, NO GUIDES |
| 00810007630571 | MANDIBLE, 2.6 FULL |
| 00810007630564 | MANDIBLE, 2.6 DOUBLE ANGLE |
| 00810007630557 | MANDIBLE, 2.6 HEMI |
| 00810007630540 | MANDIBLE, 2.6 STRAIGHT |
| 00810007630526 | MANDIBLE, 2.8 FULL |
| 00810007630519 | MANDIBLE, 2.8 DOUBLE ANGLE |
| 00810007630502 | MANDIBLE, 2.8 HEMI |
| 00810007630496 | MANDIBLE, 2.8 STRAIGHT |
| 00810007630489 | MANDIBLE, 2.0 FULL |
| 00810007630472 | MANDIBLE, 2.0 DOUBLE ANGLE |
| 00810007630465 | MANDIBLE, 2.0 HEMI |
| 00810007630458 | MANDIBLE, 2.0 STRAIGHT |
| 00810007630410 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE |
| 00810007631097 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT BUNDLED W/ ACCUPLATE, NO GUIDES |
| 00810007631080 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT BUNDLED W/ ACCUPLATE |
| 00810007631509 | MIDFACE, 2.6 PLATE |
| 00810007631493 | MIDFACE, 2.8 PLATE |
| 00810007631486 | MIDFACE, 2.0 PLATE |
| 00810007631141 | MIDFACE, 2.6 PLATE |
| 00810007631134 | MIDFACE, 2.8 PLATE |
| 00810007631127 | MIDFACE, 2.0 PLATE |
| 00810007632698 | 3D PRINTED TITANIUM MIDFACE PLATE, LARGE |
| 00810007632681 | 3D PRINTED TITANIUM MIDFACE PLATE, SMALL |
| 00810007632674 | 3D PRINTED TITANIUM MANDIBLE PLATE, LARGE |
| 00810007632667 | 3D PRINTED TITANIUM MANDIBLE PLATE, MEDIUM |
| 00810007632650 | 3D PRINTED TITANIUM MANDIBLE PLATE, SMALL |
| 00810007632643 | ORTHOGNATHIC, 3D PRINTED TITANIUM MANDIBLE PLATE, LARGE |
| 00810007632636 | ORTHOGNATHIC, 3D PRINTED TITANIUM MANDIBLE PLATE, MEDIUM |
| 00810007632629 | ORTHOGNATHIC, 3D PRINTED TITANIUM MANDIBLE PLATE, SMALL |
| 00810007632612 | ORTHOGNATHIC, 3D PRINTED TITANIUM MANDIBLE PLATE, MINI |
| 00810007632605 | ORTHOGNATHIC, 3D PRINTED TITANIUM LEFORT PLATE, LARGE |
| 00810007632599 | ORTHOGNATHIC, 3D PRINTED TITANIUM LEFORT PLATE, SMALL |
| 00810007632575 | 3D PRINTED TITANIUM ORBITAL PLATE, SMALL |
| 00810007632568 | 3D PRINTED TITANIUM MIDFACE PLATE, LARGE |
| 00810007632551 | 3D PRINTED TITANIUM MIDFACE PLATE, SMALL |
| 00810007632544 | 3D PRINTED TITANIUM MANDIBLE PLATE, LARGE |
| 00810007632537 | 3D PRINTED TITANIUM MANDIBLE PLATE, MEDIUM |
| 00810007632520 | 3D PRINTED TITANIUM MANDIBLE PLATE, SMALL |
| 00810007632513 | ORTHOGNATHIC, 3D PRINTED TITANIUM MANDIBLE PLATE, LARGE |
| 00810007632506 | ORTHOGNATHIC, 3D PRINTED TITANIUM MANDIBLE PLATE, MEDIUM |
| 00810007632490 | ORTHOGNATHIC, 3D PRINTED TITANIUM MANDIBLE PLATE, SMALL |
| 00810007632483 | ORTHOGNATHIC, 3D PRINTED TITANIUM MANDIBLE PLATE, MINI |
| 00810007632476 | ORTHOGNATHIC, 3D PRINTED TITANIUM LEFORT PLATE, LARGE |
| 00810007632469 | ORTHOGNATHIC, 3D PRINTED TITANIUM LEFORT PLATE, SMALL |
| 00810007632582 | 3D PRINTED TITANIUM ORBITAL PLATE, LARGE |
| 00810007632711 | 3D PRINTED TITANIUM ORBITAL PLATE, LARGE |
| 00810007632704 | 3D PRINTED TITANIUM ORBITAL PLATE, SMALL |
| 00810007633176 | 3DTI, MIDFACE, 3DTI 2.4 PLATE |
| 00810007633169 | 3DTI, MIDFACE, 3DTI 2.6 PLATE |
Trademark Results [AccuPlate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUPLATE 87263836 5392792 Live/Registered |
Vanduzen Inc. 2016-12-09 |
 ACCUPLATE 75075759 not registered Dead/Abandoned |
Bayer Corporation 1996-03-20 |
 ACCUPLATE 73679042 1525176 Dead/Cancelled |
ICL SCIENTIFIC, INC. 1987-08-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.