SCIENT'X CEMENT RESTRICTOR

Prosthesis, Hip, Cement Restrictor

SCIENT'X

The following data is part of a premarket notification filed by Scient'x with the FDA for Scient'x Cement Restrictor.

Pre-market Notification Details

Device IDK052367
510k NumberK052367
Device Name:SCIENT'X CEMENT RESTRICTOR
ClassificationProsthesis, Hip, Cement Restrictor
Applicant SCIENT'X 1001 OAKWOOD BLVD. Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
SCIENT'X 1001 OAKWOOD BLVD. Round Rock,  TX  78681
Product CodeJDK  
CFR Regulation Number878.3300 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-29
Decision Date2005-10-05
Summary:summary

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