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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K260546
Device Name Q Pedicle Instruments
Applicant
K2m, Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact Katie Walko
Correspondent
K2m, Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Correspondent Contact Katie Walko
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/18/2026
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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