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 | K141549 |
| 510k Number | K141549 |
| Device Name: | SImmetry Sacroiliac Joint Fusion System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Zyga Technology, Inc. 5600 Rowland Rd Suite 200 Minnetonka, MN 55343 |
| Contact | Diane Brinza |
| Correspondent | Diane Brinza Zyga Technology, Inc. 5600 Rowland Rd Suite 200 Minnetonka, MN 55343 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-11 |
| Decision Date | 2015-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817672010066 | K141549 | 000 |
| 00817672010516 | K141549 | 000 |
| 00817672010523 | K141549 | 000 |
| 00817672010547 | K141549 | 000 |
| 00817672010561 | K141549 | 000 |
| 00817672010585 | K141549 | 000 |
| 00817672010806 | K141549 | 000 |
| 00817672010820 | K141549 | 000 |
| 00817672010844 | K141549 | 000 |
| 00817672010509 | K141549 | 000 |
| 00817672010493 | K141549 | 000 |
| 00817672010073 | K141549 | 000 |
| 00817672010080 | K141549 | 000 |
| 00817672010097 | K141549 | 000 |
| 00817672010356 | K141549 | 000 |
| 00817672010363 | K141549 | 000 |
| 00817672010394 | K141549 | 000 |
| 00817672010417 | K141549 | 000 |
| 00817672010486 | K141549 | 000 |
| 00817672010936 | K141549 | 000 |
| 00817672010950 | K141549 | 000 |
| 00817672010974 | K141549 | 000 |
| 00817672011353 | K141549 | 000 |
| 00817672011360 | K141549 | 000 |
| 00817672011377 | K141549 | 000 |
| 00817672011384 | K141549 | 000 |
| 00817672011391 | K141549 | 000 |
| 00817672011636 | K141549 | 000 |
| 00817672011643 | K141549 | 000 |
| 00817672011650 | K141549 | 000 |
| 00817672011285 | K141549 | 000 |
| 00817672011261 | K141549 | 000 |
| 00817672010998 | K141549 | 000 |
| 00817672011018 | K141549 | 000 |
| 00817672011094 | K141549 | 000 |
| 00817672011117 | K141549 | 000 |
| 00817672011131 | K141549 | 000 |
| 00817672011155 | K141549 | 000 |
| 00817672011223 | K141549 | 000 |
| 00817672011247 | K141549 | 000 |
| 00817672011667 | K141549 | 000 |