The following data is part of a premarket notification filed by Devise Ortho, Inc. with the FDA for Drive Rail System.
| Device ID | K140822 |
| 510k Number | K140822 |
| Device Name: | DRIVE RAIL SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DEVISE ORTHO, INC. 3011 CENTRE OAK WAY SUITE 102 Germantown, TN 38138 |
| Contact | Alex Greene |
| Correspondent | Alex Greene DEVISE ORTHO, INC. 3011 CENTRE OAK WAY SUITE 102 Germantown, TN 38138 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817867020511 | K140822 | 000 |
| 00817867020580 | K140822 | 000 |
| 00817867020573 | K140822 | 000 |
| 00817867020566 | K140822 | 000 |
| 00817867020559 | K140822 | 000 |
| 00817867020542 | K140822 | 000 |
| 00817867020535 | K140822 | 000 |
| 00817867020528 | K140822 | 000 |
| 00817867020108 | K140822 | 000 |
| 00817867020092 | K140822 | 000 |
| 00817867020085 | K140822 | 000 |
| 00817867020078 | K140822 | 000 |
| 00817867020061 | K140822 | 000 |
| 00817867020054 | K140822 | 000 |
| 00817867020047 | K140822 | 000 |
| 00817867020030 | K140822 | 000 |
| 00817867020023 | K140822 | 000 |
| 00817867020597 | K140822 | 000 |
| 00817867020603 | K140822 | 000 |
| 00817867020610 | K140822 | 000 |
| 00817867020504 | K140822 | 000 |
| 00817867020443 | K140822 | 000 |
| 00817867020412 | K140822 | 000 |
| 00817867020405 | K140822 | 000 |
| 00817867020399 | K140822 | 000 |
| 00817867020382 | K140822 | 000 |
| 00817867020375 | K140822 | 000 |
| 00817867020368 | K140822 | 000 |
| 00817867020344 | K140822 | 000 |
| 00817867020122 | K140822 | 000 |
| 00817867020672 | K140822 | 000 |
| 00817867020665 | K140822 | 000 |
| 00817867020658 | K140822 | 000 |
| 00817867020641 | K140822 | 000 |
| 00817867020634 | K140822 | 000 |
| 00817867020627 | K140822 | 000 |
| 00817867020016 | K140822 | 000 |