SOFAMOR ORTHOPAEDIC INSTRUMENTS

Orthopedic Manual Surgical Instrument

DANEK MEDICAL, INC.

The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Sofamor Orthopaedic Instruments.

Pre-market Notification Details

Device IDK933242
510k NumberK933242
Device Name:SOFAMOR ORTHOPAEDIC INSTRUMENTS
ClassificationOrthopedic Manual Surgical Instrument
Applicant DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis,  TN  38131
ContactBrian Gooden
CorrespondentBrian Gooden
DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis,  TN  38131
Product CodeLXH  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-02
Decision Date1994-01-28

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