Quick-Start Screws

Screw, Fixation, Bone

Innovate Orthopaedics Limited

The following data is part of a premarket notification filed by Innovate Orthopaedics Limited with the FDA for Quick-start Screws.

Pre-market Notification Details

Device IDK212547
510k NumberK212547
Device Name:Quick-Start Screws
ClassificationScrew, Fixation, Bone
Applicant Innovate Orthopaedics Limited 3M Buckley Innovation Centre Firth Street Huddersfield,  GB Hd1 3bd
ContactAlex Gutteridge
CorrespondentAlex Gutteridge
Innovate Orthopaedics Limited 3M Buckley Innovation Centre Firth Street Huddersfield,  GB Hd1 3bd
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-13
Decision Date2021-12-30

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