FDA.report

510(k) K221615

Device
Newclip Patient-matched instrumentation non sterile PSI
Applicant
Newclip Technics
510(k) number
K221615
Product code
PBF
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-25
Date received
2022-06-03
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
Gaelle Gourbiere
Address
P.A. 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