SYNTHES TOMOFIX OSTEOTOMY 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 Tomofix Osteotomy System.

Pre-market Notification Details

Device IDK023941
510k NumberK023941
Device Name:SYNTHES TOMOFIX OSTEOTOMY SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-26
Decision Date2003-01-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6794408740 K023941 000
H6794408640 K023941 000
H6794408530 K023941 000
H6794408430 K023941 000
H6794408340 K023941 000
H6794133090 K023941 000

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