ARTHROSCOPIC ANKLE HOLDER

Operating Room Accessories Table Tray

ORTHOPEDIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Arthroscopic Ankle Holder.

Pre-market Notification Details

Device IDK864881
510k NumberK864881
Device Name:ARTHROSCOPIC ANKLE HOLDER
ClassificationOperating Room Accessories Table Tray
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 CodeFWZ  
CFR Regulation Number878.4950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-12
Decision Date1986-12-29

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