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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K230876
Device Name RI.KNEE Adjustable Tibia Cut Guide
Applicant
Enztec Limited
3/17 Print Place
Middleton,  NZ 8024
Applicant Contact Breanna Crowther
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/30/2023
Decision Date 06/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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