FDA.report

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

Related Records

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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