FDA.report

510(k) K242589

Device
Scarlet® AL-T
Applicant
Spineart SA
510(k) number
K242589
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-23
Date received
2024-08-30
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
Estelle Lefeuvre
Address
Chemin Du Pré-Fleuri 3 Plan-Les-Ouates CH 1228 1228

FDA Registration Numbers

Source Documents

510(k) summary PDF

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