SYNTHES IN-SITU BENDER/CUTTER

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes In-situ Bender/cutter.

Pre-market Notification Details

Device IDK021458
510k NumberK021458
Device Name:SYNTHES IN-SITU BENDER/CUTTER
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactMatthew M Hull
CorrespondentMatthew M Hull
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-07
Decision Date2002-07-24
Summary:summary

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