SPRYTIE, MODELS ST001, ST002 AND ST003

Wire, Fixation, Intraosseous

RUSSELL B. WALTHER

The following data is part of a premarket notification filed by Russell B. Walther with the FDA for Sprytie, Models St001, St002 And St003.

Pre-market Notification Details

Device IDK092530
510k NumberK092530
Device Name:SPRYTIE, MODELS ST001, ST002 AND ST003
ClassificationWire, Fixation, Intraosseous
Applicant RUSSELL B. WALTHER 6026 MARTEL AVENUE Dallas,  TX  75206
ContactRussell B Walther
CorrespondentRussell B Walther
RUSSELL B. WALTHER 6026 MARTEL AVENUE Dallas,  TX  75206
Product CodeDZK  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-18
Decision Date2010-04-02
Summary:summary

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