FDA.report

510(k) K232484

Device
KeyLift™ Expandable Interlaminar Stabilization System
Applicant
Flospine
510(k) number
K232484
Product code
PEK
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-19
Date received
2023-08-16
Regulation
888.3050
Classification name
Spinous Process Plate
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
Peter Harris
Address
3651 Fau Blvd., Suite 400 Boca Raton FL US 33431 33431

FDA Registration Numbers

Source Documents

510(k) summary PDF

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