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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K261647
Device Name Tempo Plating System; Ultra Compression Screw System
Applicant
Pace Surgical
7 Great Valley Pkwy.
Suite 295
Malvern,  PA  19355
Applicant Contact Bill Rhoda
Correspondent
MRC Global, LLC
9160 Hwy. 64 Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Danielle Besal
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/19/2026
Decision Date 09/03/2026
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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