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510(k) K241468

Vertiwedge® Intraosseous System by Foundation Surgical Group, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2024
Date Received
May 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Foundation Surgical Group, Inc.

  • K241487 — Interwedge® Standalone Lateral (October 2, 2024)

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