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510(k) K905451

SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE by Advanced Osseous Technologies — Product Code JDX

K905451 is an FDA 510(k) premarket notification submitted by Advanced Osseous Technologies for the device "SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE". The FDA issued a decision of Substantially Equivalent on March 5, 1991. The device falls under product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment), a Class II device regulated under 21 CFR 888.4580. Advanced Osseous Technologies has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1991
Date Received
December 5, 1990
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 Advanced Osseous Technologies

  • K900003 — SYSTEM TEN MODEL 100 SURGICAL SYSTEM (March 16, 1990)

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)
  • K083830 — OSCAR BONE RESECTOR (March 20, 2009)
  • K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (December 19, 2007)

FDA data resources