The following data is part of a premarket notification filed by Jace Medical, Llc with the FDA for Jace Medical Thoracic Plating System.
| Device ID | K210290 |
| 510k Number | K210290 |
| Device Name: | JACE Medical Thoracic Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | JACE Medical, LLC 3516 Commerce Drive Warsaw, IN 46850 |
| Contact | Scott Steffensmeier |
| Correspondent | Dawn N. Norman MRC Global 9085 E. Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-02 |
| Decision Date | 2021-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888233069793 | K210290 | 000 |
| 00888233069502 | K210290 | 000 |
| 00888233069496 | K210290 | 000 |
| 00888233069489 | K210290 | 000 |
| 00888233069472 | K210290 | 000 |
| 00888233069465 | K210290 | 000 |
| 00888233069427 | K210290 | 000 |
| 00888233069410 | K210290 | 000 |
| 00888233069403 | K210290 | 000 |
| 00888233069397 | K210290 | 000 |
| 00888233069366 | K210290 | 000 |
| 00888233069359 | K210290 | 000 |
| 00888233069342 | K210290 | 000 |
| 00888233069519 | K210290 | 000 |
| 00888233069526 | K210290 | 000 |
| 00888233069625 | K210290 | 000 |
| 00888233069618 | K210290 | 000 |
| 00888233069601 | K210290 | 000 |
| 00888233069595 | K210290 | 000 |
| 00888233069434 | K210290 | 000 |
| 00888233069380 | K210290 | 000 |
| 00888233069373 | K210290 | 000 |
| 00888233069588 | K210290 | 000 |
| 00888233069571 | K210290 | 000 |
| 00888233069564 | K210290 | 000 |
| 00888233069557 | K210290 | 000 |
| 00888233069540 | K210290 | 000 |
| 00888233069458 | K210290 | 000 |