The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Camber Spine Navigation System.
| Device ID | K220038 |
| 510k Number | K220038 |
| Device Name: | Camber Spine Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Camber Spine Technologies 501 Allendale Rd King Of Prussia, PA 19406 |
| Contact | Noel Hetrick |
| Correspondent | Christine Scifert MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, CO 80112 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-04-29 |