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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K252432
Device Name Flex-Z™ Cervical Cage
Applicant
Spinepoint, LLC
12975 Silver Wolf Rd.
Reno,  NV  89511
Applicant Contact Lali Sekhon
Correspondent
Spinepoint, LLC
12975 Silver Wolf Rd.
Reno,  NV  89511
Correspondent Contact Lali Sekhon
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/01/2025
Decision Date 03/25/2026
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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