LigaPASS

Bone Fixation Cerclage, Sublaminar

Medicrea International S.A.

The following data is part of a premarket notification filed by Medicrea International S.a. with the FDA for Ligapass.

Pre-market Notification Details

Device IDK172021
510k NumberK172021
Device Name:LigaPASS
ClassificationBone Fixation Cerclage, Sublaminar
Applicant Medicrea International S.A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape,  FR 69140
ContactDavid Ryan
CorrespondentDavid Ryan
Medicrea International S.A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape,  FR 69140
Product CodeOWI  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-05
Decision Date2017-08-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03613720271246 K172021 000
03613720271253 K172021 000
03613720271239 K172021 000
03613720271222 K172021 000

Trademark Results [LigaPASS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIGAPASS
LIGAPASS
79105527 4239786 Live/Registered
MEDICREA INTERNATIONAL
2011-09-26

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