FDA.reportPublic FDA data

510(k) K212811

Device
Ti3Z Lumbar Interbody System
Applicant
Zavation Medical Products, LLC
510(k) number
K212811
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-12
Date received
2021-09-03
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Katie Motley
Address
220 Lakeland Pkwy. Flowood MS US 39232 39232

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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