The following data is part of a premarket notification filed by Ellipse Technologies, Incorporated with the FDA for Precice Intramedullary Limb Lengthening System.
| Device ID | K151131 |
| 510k Number | K151131 |
| Device Name: | PRECICE Intramedullary Limb Lengthening System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Ellipse Technologies, Incorporated 13900 Alton Parkway Ste 123 Irvine, CA 92618 |
| Contact | Rebecca Shelburne |
| Correspondent | Rebecca Shelburne Ellipse Technologies, Incorporated 13900 Alton Parkway Ste 123 Irvine, CA 92618 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-28 |
| Decision Date | 2015-06-19 |
| Summary: | summary |