The following data is part of a premarket notification filed by Ellipse Technologies Inc. with the FDA for Precice Intramedullary Limb Lengthening System.
| Device ID | K131677 |
| 510k Number | K131677 |
| Device Name: | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ELLIPSE TECHNOLOGIES INC. 13900 ALTON PKWY STE 123 Irvine, CA 92618 -0000 |
| Contact | John Mcintyre |
| Correspondent | John Mcintyre ELLIPSE TECHNOLOGIES INC. 13900 ALTON PKWY STE 123 Irvine, CA 92618 -0000 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2013-10-11 |
| Summary: | summary |