The following data is part of a premarket notification filed by Zavation Medical Products Llc with the FDA for Z-span Plate System.
| Device ID | K202624 |
| 510k Number | K202624 |
| Device Name: | Z-Span Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Contact | Frankie Cummins |
| Correspondent | Frankie Cummins Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-10 |
| Decision Date | 2020-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842166167643 | K202624 | 000 |
| 00842166167636 | K202624 | 000 |
| 00842166167629 | K202624 | 000 |
| 00842166167612 | K202624 | 000 |