UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS

Orthosis, Spinal Pedicle Fixation

SEASPINE

The following data is part of a premarket notification filed by Seaspine with the FDA for Ucr Spinal System, Laminar Hooks, Pedicle Hooks, And Instruments.

Pre-market Notification Details

Device IDK031381
510k NumberK031381
Device Name:UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SEASPINE 727 PARK BLVD. San Diego,  CA  92101
ContactDiana Smith
CorrespondentDiana Smith
SEASPINE 727 PARK BLVD. San Diego,  CA  92101
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-01
Decision Date2003-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889981036201 K031381 000
10889981036195 K031381 000
10889981036188 K031381 000
10889981003029 K031381 000
10889981003012 K031381 000

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