SYNTHES LOCKING CALCANEAL PLATES

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Locking Calcaneal Plates.

Pre-market Notification Details

Device IDK991407
510k NumberK991407
Device Name:SYNTHES LOCKING CALCANEAL PLATES
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeLXT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-22
Decision Date1999-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6792416270 K991407 000
H6792416260 K991407 000
H6792416250 K991407 000
H6792416240 K991407 000
H6792416230 K991407 000
H6792416220 K991407 000
H6792416190 K991407 000
H6792416180 K991407 000

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