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510(k) K172464

XD880A Ultrasonic Osteotomy Surgical System by Morley Research Consortium — Product Code JDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2018
Date Received
August 14, 2017
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

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  • 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)