The following data is part of a premarket notification filed by Zyga Technology, Inc. with the FDA for Simmetry Sacroiliac Joint Fusion System.
Device ID | K102907 |
510k Number | K102907 |
Device Name: | SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Classification | Sacroiliac Joint Fixation |
Applicant | Zyga Technology, Inc. 700 10TH AVENUE SOUTH, SUITE 400 Minneapolis, MN 55415 |
Contact | Diane Brinza |
Correspondent | Diane Brinza Zyga Technology, Inc. 700 10TH AVENUE SOUTH, SUITE 400 Minneapolis, MN 55415 |
Product Code | OUR |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-01 |
Decision Date | 2010-12-14 |
Summary: | summary |