SPINAL WRENCH

Wrench

TWIN CITY SURGICAL, INC.

The following data is part of a premarket notification filed by Twin City Surgical, Inc. with the FDA for Spinal Wrench.

Pre-market Notification Details

Device IDK813067
510k NumberK813067
Device Name:SPINAL WRENCH
ClassificationWrench
Applicant TWIN CITY SURGICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHXC  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-30
Decision Date1981-11-24

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