CADENCE PEEK CEMEENT RESTRICTOR

Prosthesis, Hip, Cement Restrictor

SPINAL CONCEPTS, INC.

The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Cadence Peek Cemeent Restrictor.

Pre-market Notification Details

Device IDK023647
510k NumberK023647
Device Name:CADENCE PEEK CEMEENT RESTRICTOR
ClassificationProsthesis, Hip, Cement Restrictor
Applicant SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin,  TX  78727
ContactAudrey Swearingen
CorrespondentAudrey Swearingen
SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin,  TX  78727
Product CodeJDK  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-30
Decision Date2002-11-27
Summary:summary

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