The following data is part of a premarket notification filed by Zavation, Llc with the FDA for Z-span Plate System.
| Device ID | K160362 |
| 510k Number | K160362 |
| Device Name: | Z-Span Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Zavation, LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Contact | Frankie Cummins |
| Correspondent | Frankie Cummins Zavation, 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 | 2016-02-09 |
| Decision Date | 2016-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842166121072 | K160362 | 000 |
| 00842166196858 | K160362 | 000 |
| 00842166121089 | K160362 | 000 |
| 00842166121096 | K160362 | 000 |
| 00842166121102 | K160362 | 000 |
| 00842166121119 | K160362 | 000 |
| 00842166121126 | K160362 | 000 |
| 00842166121133 | K160362 | 000 |
| 00842166121140 | K160362 | 000 |
| 00842166121157 | K160362 | 000 |
| 00842166121164 | K160362 | 000 |
| 00842166121171 | K160362 | 000 |
| 00842166121188 | K160362 | 000 |
| 00842166121195 | K160362 | 000 |
| 00842166192621 | K160362 | 000 |
| 00842166183421 | K160362 | 000 |
| 00842166121058 | K160362 | 000 |
| 00842166121065 | K160362 | 000 |
| 00842166196841 | K160362 | 000 |