The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Siconus Si Joint Fixation System.
| Device ID | K162121 |
| 510k Number | K162121 |
| Device Name: | Siconus SI Joint Fixation System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | CAMBER SPINE TECHNOLOGIES 418 E. LANCASTER AVE Wayne, PA 19087 |
| Contact | Damian Heinz |
| Correspondent | Justin Eggleton MCRA, LLC 1331 H ST NW, 12TH FL Washington, DC 20005 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2017-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B030SCL110650 | K162121 | 000 |
| G418VYFI110600 | K162121 | 000 |
| G418VYFI110550 | K162121 | 000 |
| G418VYFI110500 | K162121 | 000 |
| G418VYFI110450 | K162121 | 000 |
| G418VYFI110400 | K162121 | 000 |
| G418VYFI110350 | K162121 | 000 |
| G418VYFI070700 | K162121 | 000 |
| G418VYFI070650 | K162121 | 000 |
| G418VYFI070600 | K162121 | 000 |
| G418VYFI070550 | K162121 | 000 |
| G418VYFI070500 | K162121 | 000 |
| G418VYFI070450 | K162121 | 000 |
| G418VYFI070400 | K162121 | 000 |
| G418VYFI070350 | K162121 | 000 |
| G418VYFI110650 | K162121 | 000 |
| B030SCL070300 | K162121 | 000 |
| B030SCL110600 | K162121 | 000 |
| B030SCL110550 | K162121 | 000 |
| B030SCL110500 | K162121 | 000 |
| B030SCL110450 | K162121 | 000 |
| B030SCL110400 | K162121 | 000 |
| B030SCL110350 | K162121 | 000 |
| B030SCL070700 | K162121 | 000 |
| B030SCL070650 | K162121 | 000 |
| B030SCL070600 | K162121 | 000 |
| B030SCL070550 | K162121 | 000 |
| B030SCL070500 | K162121 | 000 |
| B030SCL070450 | K162121 | 000 |
| B030SCL070400 | K162121 | 000 |
| B030SCL070350 | K162121 | 000 |
| G418VYFI070300 | K162121 | 000 |