The following data is part of a premarket notification filed by Zavation Medical Products Llc with the FDA for Z-linkpc System.
| Device ID | K211993 |
| 510k Number | K211993 |
| Device Name: | Z-LINKPC System |
| Classification | Posterior Cervical Screw System |
| Applicant | Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Contact | Colby Williams |
| Correspondent | Colby Williams Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-08-11 |