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510(k) K091227

PIEZOSURGERY 3; OSSTEM PIEZO by Piezosurgery S.R.L. — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2009
Date Received
April 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Piezosurgery S.R.L.

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  • K043408 — PIEZOSURGERY DEVICE (June 8, 2005)

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  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)
  • K171326 — Piezosurgery White (April 13, 2018)
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