FDA.report

510(k) K212070

Device
KMTI S141 Lumbar Interbody Fusion System
Applicant
Kyocera Medical Technologies, Inc.
510(k) number
K212070
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-30
Date received
2021-07-02
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Anthony DeBenedictis
Address
1200 California St. Suite 210 Redlands CA US 92374 92374

FDA Registration Numbers

Source Documents

510(k) summary PDF

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