The following data is part of a premarket notification filed by Addivation Medical, Llc with the FDA for Addivation Medical Cervical Interbody System.
| Device ID | K190291 |
| 510k Number | K190291 |
| Device Name: | Addivation Medical Cervical Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Addivation Medical, LLC 44 Riverdale Avenue Monmouth Beach, NJ 07750 |
| Contact | Gregory Stebbins |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-11 |
| Decision Date | 2019-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B804AOCS61491 | K190291 | 000 |
| B804AOCS61211 | K190291 | 000 |
| B804AOCS61221 | K190291 | 000 |
| B804AOCS61251 | K190291 | 000 |
| B804AOCS61261 | K190291 | 000 |
| B804AOCS61271 | K190291 | 000 |
| B804AOCS61281 | K190291 | 000 |
| B804AOCS61291 | K190291 | 000 |
| B804AOCS61401 | K190291 | 000 |
| B804AOCS61411 | K190291 | 000 |
| B804AOCS61421 | K190291 | 000 |
| B804AOCS61451 | K190291 | 000 |
| B804AOCS61461 | K190291 | 000 |
| B804AOCS61471 | K190291 | 000 |
| B804AOCS61481 | K190291 | 000 |
| B804AOCS61201 | K190291 | 000 |