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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Finger, Constrained, Polymer
510(k) Number K233670
Device Name Ascension Silicone MCP; Ascension Silicone PIP
Applicant
Ascension Orthopedics, Inc.
11101 Metric Blvd.
Austin,  TX  78758
Applicant Contact Omunique Luke
Correspondent
Ascension Orthopedics, Inc.
11101 Metric Blvd.
Austin,  TX  78758
Correspondent Contact Omunique Luke
Regulation Number888.3230
Classification Product Code
KYJ  
Date Received11/15/2023
Decision Date 12/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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