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510(k) K241034

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System by Medacta International S.A. — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2024
Date Received
April 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Posterior Screw Augmentation
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

The device is intended to augment the fixation of screws in a posterior spinal system construct.

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