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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K251555
Device Name Ultra™ Compression Screw System
Applicant
Pace Surgical
7 Great Valley Pkwy.
Suite 295
Malvern,  PA  19355
Applicant Contact Bill Rhoda
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received05/21/2025
Decision Date 11/06/2025
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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