1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 1.3 & 1.5mm Contourable Titanium (ti.) Mesh Plates.

Pre-market Notification Details

Device IDK033121
510k NumberK033121
Device Name:1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
ClassificationPlate, Bone
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-30
Decision Date2003-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9804460550 K033121 000
H9804460150 K033121 000
H9804460140 K033121 000
H9804210200 K033121 000
H9804210170 K033121 000
H9804210150 K033121 000
H9804210090 K033121 000
H980421008S0 K033121 000
H9804210080 K033121 000
H9804210070 K033121 000
H9804210050 K033121 000
H9804460170 K033121 000
H9804460180 K033121 000
H980446054S0 K033121 000
H9804460540 K033121 000
H9804460530 K033121 000
H9804460520 K033121 000
H980446051S0 K033121 000
H980446050S0 K033121 000
H980446036S0 K033121 000
H980446035S0 K033121 000
H980446034S0 K033121 000
H980446033S0 K033121 000
H9804210040 K033121 000

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