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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Arthroscope
510(k) Number K252666
Device Name Articulator Arthroscopic Bur
Applicant
Joint Preservation Innovations, LLC
115 E. Ogden Ave.
Suite 105-323
Naperville,  IL  60563
Applicant Contact Sanjeev Bhatia
Correspondent
Medical Device Academy
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Rob Packard
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/25/2025
Decision Date 11/21/2025
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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