OCTAGONAL ALUMINUM FRAMING SYSTEM

Apparatus, Traction, Non-powered

ORTHOPEDIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Octagonal Aluminum Framing System.

Pre-market Notification Details

Device IDK823372
510k NumberK823372
Device Name:OCTAGONAL ALUMINUM FRAMING SYSTEM
ClassificationApparatus, Traction, Non-powered
Applicant ORTHOPEDIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHST  
CFR Regulation Number888.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-12
Decision Date1982-12-03

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