HEDROCEL ACETABULAR RESTRICTOR

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

IMPLEX CORP.

The following data is part of a premarket notification filed by Implex Corp. with the FDA for Hedrocel Acetabular Restrictor.

Pre-market Notification Details

Device IDK962468
510k NumberK962468
Device Name:HEDROCEL ACETABULAR RESTRICTOR
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant IMPLEX CORP. 1700 ROCKVILLE PIKE SUITE 450 Rockville,  MD  20852
ContactGary J Sfeir
CorrespondentGary J Sfeir
IMPLEX CORP. 1700 ROCKVILLE PIKE SUITE 450 Rockville,  MD  20852
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-25
Decision Date1997-02-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024306240 K962468 000
00889024306233 K962468 000
00889024306226 K962468 000

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