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510(k) K972308

MEDNEXT 1000 DRILL by Mednext, Inc. — Product Code GEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1997
Date Received
June 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Mednext, Inc.

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  • 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 GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)
  • K962789 — SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (August 14, 1996)