COMPRESSION HIP SCREW SYSTEM

Media And Components, Synthetic Cell And Tissue Culture

PFIZER, INC.

The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Compression Hip Screw System.

Pre-market Notification Details

Device IDK850886
510k NumberK850886
Device Name:COMPRESSION HIP SCREW SYSTEM
ClassificationMedia And Components, Synthetic Cell And Tissue Culture
Applicant PFIZER, INC. 235 E 42ND ST. Ny,  NY  10017
ContactRonald Duchene
CorrespondentRonald Duchene
PFIZER, INC. 235 E 42ND ST. Ny,  NY  10017
Product CodeKIT  
CFR Regulation Number864.2220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-04
Decision Date1985-04-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.