SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER

Washer, Bolt Nut

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Titanium Locked Spiked Washer.

Pre-market Notification Details

Device IDK924455
510k NumberK924455
Device Name:SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER
ClassificationWasher, Bolt Nut
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactDiane Cochet-wynant
CorrespondentDiane Cochet-wynant
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 Received1992-09-02
Decision Date1993-05-12

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