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510(k) K942108

COHORT BONE BRUSH by Advanced Med/Surg, Inc. — Product Code HWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1994
Date Received
May 2, 1994
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 Advanced Med/Surg, Inc.

  • K931538 — AMSET(TM) CANNULATED BONE SCREW (May 4, 1994)
  • K921644 — AMSEN HOCKEY STICK CHISEL (June 3, 1992)
  • K921643 — AMSEN POSTERIOR DISC EVACUATOR (June 3, 1992)
  • K921642 — AMSEN DOUBLE-ENDED FORAMINAL PROBE (June 3, 1992)
  • K921645 — AMSEN SPINE IMPACTOR INSTRUMENTS (June 3, 1992)
  • K905023 — AMSET LOCKING PLATE SYSTEM (January 31, 1992)
  • K911768 — AMSET(TM) BONE SCREW (October 4, 1991)
  • K905014 — AMSET PLD SYSTEM (April 1, 1991)
  • K903808 — AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (January 22, 1991)

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  • 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)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)