Pisces Spinal System

Thoracolumbosacral Pedicle Screw System

Ortho Development Corporation

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Pisces Spinal System.

Pre-market Notification Details

Device IDK203023
510k NumberK203023
Device Name:Pisces Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Ortho Development Corporation 12187 South Business Park Drive Draper,  UT  84020
ContactDivya Palan
CorrespondentDarlene Hull
Ortho Development Corporation 12187 South Business Park Drive Draper,  UT  84020
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-02
Decision Date2021-07-14

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