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510(k) K220131

KYPHON VuE Bone Cement by Tecres S.P.A. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2022
Date Received
January 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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  • K063438 — VSPSPN (January 17, 2007)

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