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510(k) K191423

Normandy VBR System by Zavation Medical Products, LLC — Product Code PLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2019
Date Received
May 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Vertebral body replacement in the cervical spine.

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  • K190284 — Bengal Stackable Cage System (December 20, 2019)
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