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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Hemi-, Phalangeal
510(k) Number K250074
Device Name HYALEX® MTP Hemiarthroplasty Implant
Applicant
Hyalex Orthopaedics, Inc.
99 Hayden Ave.
Bldg. D, Suite 340
Lexington,  MA  02421
Applicant Contact Chris Cain
Correspondent
Hyalex Orthopaedics, Inc.
99 Hayden Ave.
Bldg. D, Suite 340
Lexington,  MA  02421
Correspondent Contact Chris Cain
Regulation Number888.3730
Classification Product Code
KWD  
Date Received01/10/2025
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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