The following data is part of a premarket notification filed by Zavation, Llc with the FDA for Z-link Cervical.
| Device ID | K141005 |
| 510k Number | K141005 |
| Device Name: | Z-LINK CERVICAL |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | ZAVATION, LLC 400 LIBERTY PARK Flowood, MS 39232 |
| Contact | John Walker |
| Correspondent | John Walker ZAVATION, LLC 400 LIBERTY PARK Flowood, MS 39232 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-18 |
| Decision Date | 2014-08-07 |
| Summary: | summary |