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510(k) K926547

MEDNEXT 1000 BONE DISSECTING SYSTEM by Mednext, Inc. — Product Code HSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
December 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & 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)
  • 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)

Other clearances for product code HSZ

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  • K972860 — CURVTEK TSR SYSTEM (October 31, 1997)
  • K970345 — ALIGNMENT INSTRUMENT (April 29, 1997)
  • K955084 — ASPACH 65,000 (MODIFICATION) (January 17, 1996)
  • K954080 — SODEM HIGH SPEED SYSTEM (October 16, 1995)
  • K944590 — ETHICON DRILL BIT AND DRILL GUIDE (May 11, 1995)
  • K934336 — SPINALPLANE (March 10, 1995)
  • K940276 — FILTER, DIFFUSER (November 16, 1994)
  • K942760 — PNEUMATIC WIRE TENSIONER (September 6, 1994)
  • K941681 — ARTHREX CIRCULAR HARVESTING SAW (August 25, 1994)