ULNAR FRACTURE BRACE

Orthosis, Limb Brace

ORTHOMEDICS

The following data is part of a premarket notification filed by Orthomedics with the FDA for Ulnar Fracture Brace.

Pre-market Notification Details

Device IDK802908
510k NumberK802908
Device Name:ULNAR FRACTURE BRACE
ClassificationOrthosis, Limb Brace
Applicant ORTHOMEDICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIQI  
CFR Regulation Number890.3475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-17
Decision Date1980-12-17

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