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 | K131490 |
| 510k Number | K131490 |
| Device Name: | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ELLIPSE TECHNOLOGIES, INC. 13900 ALTON PARKWAY SUITE 123 Irvine, CA 92618 |
| Contact | John Mcintyre |
| Correspondent | John Mcintyre ELLIPSE TECHNOLOGIES, INC. 13900 ALTON PARKWAY SUITE 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 | 2013-05-23 |
| Decision Date | 2014-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812258026530 | K131490 | 000 |
| 00195377099105 | K131490 | 000 |
| 00887517969101 | K131490 | 000 |
| 00887517969118 | K131490 | 000 |
| 00887517969125 | K131490 | 000 |
| 00887517969132 | K131490 | 000 |
| 00812258022884 | K131490 | 000 |
| 00812258022891 | K131490 | 000 |
| 00812258022907 | K131490 | 000 |
| 00812258026509 | K131490 | 000 |
| 00812258026516 | K131490 | 000 |
| 00812258026523 | K131490 | 000 |
| 00195377097309 | K131490 | 000 |