STAX FINGER SPLINTS

Splint, Hand, And Components

ORTHOPEDIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Stax Finger Splints.

Pre-market Notification Details

Device IDK823393
510k NumberK823393
Device Name:STAX FINGER SPLINTS
ClassificationSplint, Hand, And Components
Applicant ORTHOPEDIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeILH  
CFR Regulation Number890.3475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-12
Decision Date1982-12-03

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