SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM

Nail, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Cannulated Titanium Humeral Nail System.

Pre-market Notification Details

Device IDK033071
510k NumberK033071
Device Name:SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
ClassificationNail, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeJDS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-29
Decision Date2003-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67904001210S0 K033071 000
H67904001410S0 K033071 000
H67904001418S0 K033071 000
H67904001420S0 K033071 000
H67904001422S0 K033071 000
H67904001424S0 K033071 000
H67904001426S0 K033071 000
H67904001428S0 K033071 000
H67904001430S0 K033071 000
H67904001432S0 K033071 000
H67904001434S0 K033071 000
H67904001436S0 K033071 000
H67904001438S0 K033071 000
H67904001244S0 K033071 000
H67904001242S0 K033071 000
H67904001218S0 K033071 000
H67904001220S0 K033071 000
H67904001222S0 K033071 000
H67904001224S0 K033071 000
H67904001226S0 K033071 000
H67904001228S0 K033071 000
H67904001230S0 K033071 000
H67904001232S0 K033071 000
H67904001234S0 K033071 000
H67904001236S0 K033071 000
H67904001238S0 K033071 000
H67904001240S0 K033071 000
H67904001440S0 K033071 000
H67904001442S0 K033071 000
H67904001444S0 K033071 000
H67904001644S0 K033071 000
H67904001000S0 K033071 000
H679040010000 K033071 000
H679040010010 K033071 000
H67904001001S0 K033071 000
H679040010020 K033071 000
H67904001002S0 K033071 000
H679040010030 K033071 000
H67904001003S0 K033071 000
H67904001007S0 K033071 000
H67904001008S0 K033071 000
H67904001009S0 K033071 000
H67904001642S0 K033071 000
H67904001640S0 K033071 000
H67904001610S0 K033071 000
H67904001618S0 K033071 000
H67904001620S0 K033071 000
H67904001622S0 K033071 000
H67904001624S0 K033071 000
H67904001626S0 K033071 000
H67904001628S0 K033071 000
H67904001630S0 K033071 000
H67904001632S0 K033071 000
H67904001634S0 K033071 000
H67904001636S0 K033071 000
H67904001638S0 K033071 000
H67904001010S0 K033071 000

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