The following data is part of a premarket notification filed by Ackermann Instrumente Gmbh with the FDA for Ackermann Intervertebral Body Fusion Device.
| Device ID | K143450 |
| 510k Number | K143450 |
| Device Name: | Ackermann Intervertebral Body Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ACKERMANN INSTRUMENTE GMBH EISENBAHNSTR. 65-67 Rietheim, Weilheim, DE D-78604 |
| Contact | Rolf Ackermann |
| Correspondent | Frank Ferguson Ferguson Medical International Device Consultants LLC 332 Laskin Road, Suite 437 Virginia Beach, VA 23451 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-02 |
| Decision Date | 2015-09-16 |
| Summary: | summary |