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K232561

Ripley Spinal Screw System by SAGICO

510(k) number
K232561
Device name
Ripley Spinal Screw System by SAGICO
Applicant
Sagico VA USA, LLC FL · US
Product code
NKB — Thoracolumbosacral Pedicle Screw System
Decision date
2023-10-23
Date received
2023-08-24
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
510(k) Summary (official FDA PDF): K232561.pdf
Official FDA record: K232561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.