FDA.report

510(k) K240415

Device
Newclip Patient-matched instrumentation non sterile PSI
Applicant
Newclip Technics
510(k) number
K240415
Product code
PBF
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-07
Date received
2024-02-12
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
No

Related Records

Applicant Contact

Contact
Robert Poggie
Address
Pa De La Lande Saint Martin 45 Rue Des Garottieres Haute Goulaine FR 44115 44115

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K220706MyPAO GuidesMedacta International S.A.2023-05-30