MENISCAL SUTURING SYSTEM

Orthopedic Manual Surgical Instrument

DYONICS, INC.

The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Meniscal Suturing System.

Pre-market Notification Details

Device IDK833943
510k NumberK833943
Device Name:MENISCAL SUTURING SYSTEM
ClassificationOrthopedic Manual Surgical Instrument
Applicant DYONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLXH  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-15
Decision Date1984-02-27

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