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510(k) K970023

MEDNEXT SURGICAL BUR by Mednext, Inc. — Product Code HWE

K970023 is an FDA 510(k) premarket notification submitted by Mednext, Inc. for the device "MEDNEXT SURGICAL BUR". The FDA issued a decision of Substantially Equivalent on February 28, 1997. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Mednext, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1997
Date Received
January 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Mednext, Inc.

  • K983092 — TRITON HUDSON CHUCK ATTACHMENT (November 6, 1998)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K943108 — MEDNEXT MICRO-DRILL (August 17, 1994)
  • K935861 — MEDNEXT BUR (May 3, 1994)
  • K935584 — MEDNEXT BUR (February 22, 1994)
  • K926547 — MEDNEXT 1000 BONE DISSECTING SYSTEM (July 22, 1993)

Other clearances for product code HWE

  • K143191 — IntelliSense Drill (February 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)

FDA data resources