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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 K231819
Device Name Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Applicant
Innovate Orthopaedics Limited
The Globe, Bridge St., Slaithwaite
Huddersfield,  GB HD7 5JN
Applicant Contact Mike Bilson
Correspondent
Innovate Orthopaedics Limited
The Globe, Bridge St., Slaithwaite
Huddersfield,  GB HD7 5JN
Correspondent Contact Mike Bilson
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/21/2023
Decision Date 09/05/2023
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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