The following data is part of a premarket notification filed by Camber Spine Technologies, Llc with the FDA for Camber Sacroiliac (si) Fixation System.
| Device ID | K203503 |
| 510k Number | K203503 |
| Device Name: | Camber Sacroiliac (SI) Fixation System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Camber Spine Technologies, LLC 501 Allendale Road King Of Prussia, PA 19604 |
| Contact | Daniel A. Pontecorvo |
| Correspondent | Christine Scifert MRC Global 9085 East Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-30 |
| Decision Date | 2022-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G418VYV1232608130 | K203503 | 000 |
| G418VYV1232608110 | K203503 | 000 |
| G418VYV1232608090 | K203503 | 000 |
| G418VYV11033210 | K203503 | 000 |
| G418VYV1103121040 | K203503 | 000 |
| G418VYV11031210 | K203503 | 000 |