ACE/KYLE CAPTURED HIP SCREW

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

ACE ORTHOPEDIC MANUFACTURING CO.

The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Ace/kyle Captured Hip Screw.

Pre-market Notification Details

Device IDK813554
510k NumberK813554
Device Name:ACE/KYLE CAPTURED HIP SCREW
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant ACE ORTHOPEDIC MANUFACTURING CO. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-22
Decision Date1982-01-12

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