The following data is part of a premarket notification filed by Ellipse Technologies, Inc. with the FDA for Ellipse Precice Intramedullary Limb Lengthening System.
| Device ID | K113219 |
| 510k Number | K113219 |
| Device Name: | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ELLIPSE TECHNOLOGIES, INC. 13900 Alton Pkwy Ste 123 Irvine, CA 92618 |
| Contact | John Mclntyre |
| Correspondent | John Mclntyre ELLIPSE TECHNOLOGIES, INC. 13900 Alton Pkwy Ste 123 Irvine, CA 92618 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-01 |
| Decision Date | 2012-10-19 |
| Summary: | summary |