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510(k) K083830

OSCAR BONE RESECTOR by Orthosonics, Ltd. — Product Code JDX

K083830 is an FDA 510(k) premarket notification submitted by Orthosonics, Ltd. for the device "OSCAR BONE RESECTOR". The FDA issued a decision of Substantially Equivalent on March 20, 2009. The device falls under product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment), a Class II device regulated under 21 CFR 888.4580. Orthosonics, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2009
Date Received
December 23, 2008
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 Orthosonics, Ltd.

  • K093805 — OSCAR 3 (February 19, 2010)
  • K051053 — OSCAR, MODEL OE3000DB (July 21, 2005)
  • K021502 — OSCAR, MODEL OE3000 (June 6, 2002)

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)
  • K153743 — PIEZOSURGERY PLUS (May 25, 2016)
  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K100410 — PIEZOELECTRIC SYSTEM (April 28, 2010)
  • K093805 — OSCAR 3 (February 19, 2010)
  • K083284 — PIEZOSURGERY MEDICAL (April 8, 2009)
  • K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (December 19, 2007)
  • K051053 — OSCAR, MODEL OE3000DB (July 21, 2005)

FDA data resources