The following data is part of a premarket notification filed by Zavation Llc with the FDA for Zavation Cervical Plate System.
| Device ID | K130030 |
| 510k Number | K130030 |
| Device Name: | ZAVATION CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ZAVATION LLC 501 AVALON WAY Brandon, MS 39047 |
| Contact | John Walker |
| Correspondent | John Walker ZAVATION LLC 501 AVALON WAY Brandon, MS 39047 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-04 |
| Decision Date | 2013-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842166109209 | K130030 | 000 |