The following data is part of a premarket notification filed by Ellipse Technologies, Incorporated with the FDA for Precice Trauma Nail System.
| Device ID | K160267 |
| 510k Number | K160267 |
| Device Name: | PRECICE Trauma Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Ellipse Technologies, Incorporated 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 |
| Contact | Cora Sim |
| Correspondent | Cora Sim Ellipse Technologies, Incorporated 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 | 2016-02-02 |
| Decision Date | 2016-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812258028077 | K160267 | 000 |
| 00812258027858 | K160267 | 000 |
| 00812258027841 | K160267 | 000 |
| 00812258027834 | K160267 | 000 |
| 00812258027827 | K160267 | 000 |
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| 00812258027803 | K160267 | 000 |
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| 00812258027773 | K160267 | 000 |
| 00812258027766 | K160267 | 000 |
| 00812258027759 | K160267 | 000 |
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| 00812258027209 | K160267 | 000 |
| 00812258027865 | K160267 | 000 |
| 00812258027872 | K160267 | 000 |
| 00812258027889 | K160267 | 000 |
| 00812258028060 | K160267 | 000 |
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| 00812258028046 | K160267 | 000 |
| 00812258028039 | K160267 | 000 |
| 00812258028015 | K160267 | 000 |
| 00812258028008 | K160267 | 000 |
| 00812258027995 | K160267 | 000 |
| 00812258027988 | K160267 | 000 |
| 00812258027971 | K160267 | 000 |
| 00812258027964 | K160267 | 000 |
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| 00812258027933 | K160267 | 000 |
| 00812258027926 | K160267 | 000 |
| 00812258027919 | K160267 | 000 |
| 00812258027902 | K160267 | 000 |
| 00812258027896 | K160267 | 000 |
| 00887517000033 | K160267 | 000 |