PASS LP SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

MEDICREA TECHNOLOGIES

The following data is part of a premarket notification filed by Medicrea Technologies with the FDA for Pass Lp Spinal System.

Pre-market Notification Details

Device IDK083308
510k NumberK083308
Device Name:PASS LP SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock,  TX  78681
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-10
Decision Date2008-12-10
Summary:summary

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