The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Ambassador.
| Device ID | K143576 |
| 510k Number | K143576 |
| Device Name: | Exactech Ambassador |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | EXACTECH, INC. 2320 NW 66TH COURT Gainesville, FL 32653 |
| Contact | Dawn Davisson |
| Correspondent | Kenneth C Maxwell Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-17 |
| Decision Date | 2015-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996174633 | K143576 | 000 |
| 00840996183154 | K143576 | 000 |
| 00840996157476 | K143576 | 000 |
| 00840996157490 | K143576 | 000 |
| 00840996169189 | K143576 | 000 |
| 00840996174589 | K143576 | 000 |
| 00840996174596 | K143576 | 000 |
| 00840996174602 | K143576 | 000 |
| 00840996174619 | K143576 | 000 |
| 00840996174626 | K143576 | 000 |
| 00840996182621 | K143576 | 000 |