SYNTHES SCHUHLI IMPLANT SYSTEM

Washer, Bolt Nut

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Schuhli Implant System.

Pre-market Notification Details

Device IDK980944
510k NumberK980944
Device Name:SYNTHES SCHUHLI IMPLANT SYSTEM
ClassificationWasher, Bolt Nut
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-12
Decision Date1998-04-27
Summary:summary

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