FDA.report

510(k) K243912

Device
Newclip Patient-matched instrumentation non sterile PSI
Applicant
Newclip Technics
510(k) number
K243912
Product code
PBF
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-13
Date received
2024-12-19
Regulation
888.3030
Classification name
Orthopaedic Surgical Planning And Instrument Guides
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
Gaëlle Gourbiere
Address
Pa De La Lande Saint Martin 45 Rue Des Garottières Haute Goulaine FR 44115 44115

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.2024-03-18
K240066Fine Osteotomy™Bodycad Laboratories, Inc.2024-02-09
K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics2023-10-25
K223421MedCAD AccuPlan Orthopedics SystemMedcad2023-09-20
K231314Fine Osteotomy™Bodycad Laboratories, Inc.2023-06-02
K220706MyPAO GuidesMedacta International S.A.2023-05-30