The following data is part of a premarket notification filed by Ellipse Technologies Incorporated with the FDA for Precice Trauma Nail System.
| Device ID | K152370 |
| 510k Number | K152370 |
| Device Name: | PRECICE Trauma Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Ellipse Technologies Incorporated 13900 Alton Parkway Ste 123 Irvine, CA 92618 |
| Contact | John Mcintyre |
| Correspondent | John Mcintyre Ellipse Technologies Incorporated 101 Enterprise Suite 100 Aliso Viejo, CA 92656 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-21 |
| Decision Date | 2015-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812258028329 | K152370 | 000 |
| 00812258022730 | K152370 | 000 |