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 | K110512 |
| 510k Number | K110512 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-23 |
| Decision Date | 2011-03-23 |
| Summary: | summary |