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510(k) K983092

TRITON HUDSON CHUCK ATTACHMENT by Mednext, Inc. — Product Code HBB

K983092 is an FDA 510(k) premarket notification submitted by Mednext, Inc. for the device "TRITON HUDSON CHUCK ATTACHMENT". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Mednext, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1998
Date Received
September 3, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type

Other clearances by Mednext, Inc.

  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K970023 — MEDNEXT SURGICAL BUR (February 28, 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 HBB

  • K253772 — Velocity Alpha MR High Speed Surgical Drill System (March 6, 2026)
  • K172907 — ELAN 4 Air Motor System (November 9, 2018)
  • K163182 — Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorpo (March 23, 2017)
  • K150801 — Stryker Maestro Air Motors (May 22, 2015)
  • K101168 — LEGEND POWER ADAPTER MODEL: 6475000 (August 24, 2010)
  • K093361 — SYNTHES AIR PEN DRIVE (APD) SYSTEM (April 14, 2010)
  • K090112 — MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC (March 26, 2009)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K061725 — STRYKER ARIA PNEUMATIC SYSTEM (October 26, 2006)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)

FDA data resources