The following data is part of a premarket notification filed by Camber Spine Technologies Llc with the FDA for Fortico Anterior Cervical Fixation System.
| Device ID | K191584 |
| 510k Number | K191584 |
| Device Name: | FORTICO Anterior Cervical Fixation System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Camber Spine Technologies LLC 501 Allendale Road King Of Prussia, PA 19406 |
| Contact | Rami Hamzey |
| Correspondent | Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B030FCP307E0 | K191584 | 000 |
| B030FCP2432E0 | K191584 | 000 |
| B030FCP2433E0 | K191584 | 000 |
| B030FCP2434E0 | K191584 | 000 |
| B030FCP2435E0 | K191584 | 000 |
| B030FCP2436E0 | K191584 | 000 |
| B030FCP310E0 | K191584 | 000 |
| B030FCP311E0 | K191584 | 000 |
| B030FCP312E0 | K191584 | 000 |
| B030FCP2437E0 | K191584 | 000 |
| B030FCP2438E0 | K191584 | 000 |
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