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 | K160325 |
| 510k Number | K160325 |
| Device Name: | PRECICE Intramedullary Limb Lengthening System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ELLIPSE TECHNOLOGIES, INC. 101 ENTERPRISE, SUITE 100 Aliso Viejo, CA 92656 |
| Contact | Cora Sim |
| Correspondent | Cora Sim ELLIPSE TECHNOLOGIES, INC. 101 ENTERPRISE, SUITE 100 Aliso Viejo, CA 92656 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-05 |
| Decision Date | 2016-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812258028282 | K160325 | 000 |
| 00812258028275 | K160325 | 000 |
| 00812258028268 | K160325 | 000 |
| 00812258028251 | K160325 | 000 |
| 00812258028244 | K160325 | 000 |
| 00812258028237 | K160325 | 000 |
| 00812258028220 | K160325 | 000 |
| 00812258028213 | K160325 | 000 |