The following data is part of a premarket notification filed by Ellipse Technologies Incorporated with the FDA for Precice Trauma Nail System.
Device ID | K152370 |
510k Number | K152370 |
Device Name: | PRECICE Trauma Nail System |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | Ellipse Technologies Incorporated 13900 Alton Parkway Ste 123 Irvine, CA 92618 |
Contact | John Mcintyre |
Correspondent | John Mcintyre Ellipse Technologies Incorporated 101 Enterprise Suite 100 Aliso Viejo, CA 92656 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-21 |
Decision Date | 2015-12-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00812258028329 | K152370 | 000 |
00812258022730 | K152370 | 000 |