SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM

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

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cannulated Angle Blade Plate (cabp) System.

Pre-market Notification Details

Device IDK974537
510k NumberK974537
Device Name:SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-03
Decision Date1998-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679237043S0 K974537 000
H679237106S0 K974537 000
H679237123S0 K974537 000
H679237124S0 K974537 000
H679237125S0 K974537 000
H679237143S0 K974537 000
H679237144S0 K974537 000
H679237145S0 K974537 000
H679237146S0 K974537 000
H679437043S0 K974537 000
H679237105S0 K974537 000
H679237104S0 K974537 000
H679237044S0 K974537 000
H679237053S0 K974537 000
H679237054S0 K974537 000
H679237063S0 K974537 000
H679237064S0 K974537 000
H679237083S0 K974537 000
H679237084S0 K974537 000
H679237085S0 K974537 000
H679237086S0 K974537 000
H679437044S0 K974537 000
H679437053S0 K974537 000
H679437054S0 K974537 000
H679437124S0 K974537 000
H679437125S0 K974537 000
H679437126S0 K974537 000
H679437143S0 K974537 000
H679437144S0 K974537 000
H679437145S0 K974537 000
H679437146S0 K974537 000
H6792181500 K974537 000
H679237103S0 K974537 000
H679437123S0 K974537 000
H679437106S0 K974537 000
H679437063S0 K974537 000
H679437064S0 K974537 000
H679437083S0 K974537 000
H679437084S0 K974537 000
H679437085S0 K974537 000
H679437086S0 K974537 000
H679437103S0 K974537 000
H679437104S0 K974537 000
H679437105S0 K974537 000
H679237126S0 K974537 000

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