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510(k) K153743

PIEZOSURGERY PLUS by Mectron S.P.A. — Product Code JDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2016
Date Received
December 28, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Sonic And Accessory/Attachment
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

Other clearances by Mectron S.P.A.

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  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)
  • K151248 — PIEZOSURGERY WHITE (September 4, 2015)
  • K151023 — COMPACT PIEZO LED (August 5, 2015)
  • K140965 — MULTIPIEZO PRO, MULTIPIEZO (August 20, 2014)
  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K122322 — PIEZOSURGERY TOUCH (December 6, 2012)

Other clearances for product code JDX

  • K201274 — Ultrasonic Osteotomy Surgical System (February 19, 2021)
  • K172464 — XD880A Ultrasonic Osteotomy Surgical System (April 24, 2018)
  • K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece (May 19, 2017)
  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K100410 — PIEZOELECTRIC SYSTEM (April 28, 2010)
  • K093805 — OSCAR 3 (February 19, 2010)
  • K083284 — PIEZOSURGERY MEDICAL (April 8, 2009)
  • K083830 — OSCAR BONE RESECTOR (March 20, 2009)
  • K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (December 19, 2007)
  • K051053 — OSCAR, MODEL OE3000DB (July 21, 2005)