PLAMP, PLAMP PLATE, PLAMP WITH HOOK

Plate, Fixation, Bone

HOSPITAL FOR SPECIAL SURGERY

The following data is part of a premarket notification filed by Hospital For Special Surgery with the FDA for Plamp, Plamp Plate, Plamp With Hook.

Pre-market Notification Details

Device IDK942032
510k NumberK942032
Device Name:PLAMP, PLAMP PLATE, PLAMP WITH HOOK
ClassificationPlate, Fixation, Bone
Applicant HOSPITAL FOR SPECIAL SURGERY 535 EAST 70TH ST. New York,  NY  10021
ContactBruce H Robie
CorrespondentBruce H Robie
HOSPITAL FOR SPECIAL SURGERY 535 EAST 70TH ST. New York,  NY  10021
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-26
Decision Date1996-06-13
Summary:summary

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