The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Ascendant Tm Cervical Spacer System.
| Device ID | K150130 |
| 510k Number | K150130 |
| Device Name: | Ascendant TM Cervical Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Dawn Davisson |
| Correspondent | Kenneth C. Maxwell EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-21 |
| Decision Date | 2015-05-28 |
| Summary: | summary |