The following data is part of a premarket notification filed by Zavation Medical Products Llc with the FDA for Zavation Spinal System.
Device ID | K211113 |
510k Number | K211113 |
Device Name: | Zavation Spinal System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
Contact | Katie Motley |
Correspondent | Katie Motley Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-14 |
Decision Date | 2021-07-12 |
Summary: | summary |