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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K231905
Device Name Electro-Spec Steri-Caps
Applicant
Electro-Spec, Inc.
1800 Commerce Pkwy.
Franklin,  IN  46131
Applicant Contact Jeff Smith
Correspondent
Kapstone Medical
520 Elliot St.
Charlotte,  NC  28202
Correspondent Contact Guthrie Carolyn
Regulation Number888.3040
Classification Product Code
HTY  
Date Received06/29/2023
Decision Date 08/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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