The following data is part of a premarket notification filed by Osseus Fusion Systems, Llc with the FDA for Gemini-c Hybrid Cervical Interbody System.
| Device ID | K170844 |
| 510k Number | K170844 |
| Device Name: | Gemini-C Hybrid Cervical Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Osseus Fusion Systems, LLC 2703 Mockingbird Lane, Suite 102 Dallas, TX 75235 |
| Contact | Robert Pace |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-21 |
| Decision Date | 2017-07-03 |
| Summary: | summary |