FDA.report

510(k) K231811

Device
Zavation Connector System
Applicant
Zavation Medical Products, LLC
510(k) number
K231811
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-22
Date received
2023-06-21
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Noah Slack
Address
3670 Flowood Dr. Flowood MS US 39232 39232

FDA Registration Numbers

Source Documents

510(k) summary PDF

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