SYNTHES MINI EXTERNAL FIXATOR

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 Mini External Fixator.

Pre-market Notification Details

Device IDK961350
510k NumberK961350
Device Name:SYNTHES MINI EXTERNAL FIXATOR
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactAngela Silvestri
CorrespondentAngela Silvestri
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-05
Decision Date1996-06-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6792927080 K961350 000
H6793959020 K961350 000
H6793953040 K961350 000
H6793953020 K961350 000
H6793951390 K961350 000

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