MALIBU SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

SEASPINE, INC.

The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Malibu Spinal System.

Pre-market Notification Details

Device IDK072605
510k NumberK072605
Device Name:MALIBU SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SEASPINE, INC. 2302 LA MIRADA DR. Vista,  CA  92081 -7862
ContactEthel Bernal
CorrespondentEthel Bernal
SEASPINE, INC. 2302 LA MIRADA DR. Vista,  CA  92081 -7862
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-17
Decision Date2007-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889981119829 K072605 000
10889981030018 K072605 000
10889981030025 K072605 000
10889981030032 K072605 000
10889981030049 K072605 000
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10889981030063 K072605 000
10889981030070 K072605 000
10889981030087 K072605 000
10889981030094 K072605 000
10889981030100 K072605 000
10889981030117 K072605 000
10889981030124 K072605 000
10889981030131 K072605 000
10889981030148 K072605 000
10889981030155 K072605 000
10889981030162 K072605 000
10889981003593 K072605 000

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