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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 K212088
Device Name Integrity Implants Navigated Instruments
Applicant
Integrity Implants, Inc.
354 Hiatt Dr.
Palm Beach Gardens,  FL  33418
Applicant Contact Lauren Kamer
Correspondent
Telos Partners, LLC
571 Christina Lake Dr.
Lakeland,  FL  33813
Correspondent Contact Roshana Ahmed
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/06/2021
Decision Date 12/23/2021
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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