PASS LP™ Spinal System, CD Horizon™ Spinal System

Thoracolumbosacral Pedicle Screw System

Medicrea International SA

The following data is part of a premarket notification filed by Medicrea International Sa with the FDA for Pass Lp™ Spinal System, Cd Horizon™ Spinal System.

Pre-market Notification Details

Device IDK213281
510k NumberK213281
Device Name:PASS LP™ Spinal System, CD Horizon™ Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medicrea International SA 5389 Route De Strasbourg - Vancia Rillieux-la-pape,  FR 69140
ContactKarine Trogneux
CorrespondentKarine Trogneux
Medicrea International SA 5389 Route De Strasbourg - Vancia Rillieux-la-pape,  FR 69140
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-01
Decision Date2022-01-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03613720287063 K213281 000
03613720286967 K213281 000
03613720286974 K213281 000
03613720286981 K213281 000
03613720286998 K213281 000
03613720287001 K213281 000
03613720287018 K213281 000
03613720287025 K213281 000
03613720287032 K213281 000
03613720287049 K213281 000
03613720287056 K213281 000
03613720286950 K213281 000

Trademark Results [PASS LP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PASS LP
PASS LP
79060844 3718769 Live/Registered
MEDICREA INTERNATIONAL
2008-10-10

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