The following data is part of a premarket notification filed by Absolute Advantage Medical, Llc with the FDA for Accufuse Cervical System.
| Device ID | K181471 |
| 510k Number | K181471 |
| Device Name: | ACCUFUSE Cervical System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Absolute Advantage Medical, LLC 2731 Millbrook Road Fayetteville, NC 78681 |
| Contact | J.d. Webb |
| 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 | 2018-06-04 |
| Decision Date | 2018-08-29 |
| Summary: | summary |