ISOMETRIC ACL DRILL GUIDE

Motor, Surgical Instrument, Ac-powered

ORTHOPEDIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Isometric Acl Drill Guide.

Pre-market Notification Details

Device IDK853762
510k NumberK853762
Device Name:ISOMETRIC ACL DRILL GUIDE
ClassificationMotor, Surgical Instrument, Ac-powered
Applicant ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward,  CA  94545
ContactRobert R Moore
CorrespondentRobert R Moore
ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward,  CA  94545
Product CodeGEY  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-09-09
Decision Date1985-10-07

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