FDA.report

510(k) K213659

Device
LigaPASS™ 2.0 Ligament Augmentation System
Applicant
Medicrea International SA
510(k) number
K213659
Product code
OWI
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-24
Date received
2021-11-19
Regulation
888.3010
Classification name
Bone Fixation Cerclage, Sublaminar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Teal Bjoraker
Address
5389 Rte. De Strasbourg - Vancia Rillieux-La-Pape FR 69140 69140

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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