Home / 510(k) Clearances / K952543

510(k) K952543

GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET by Neoligaments, Ltd. — Product Code HWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1995
Date Received
May 18, 1995
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 Neoligaments, Ltd.

  • K941772 — CRADLE FIXATION DEVICE (August 7, 1995)
  • K935753 — THE GRAFTOLOGER (April 25, 1994)
  • K930339 — REAMER BIT (August 6, 1993)
  • K913461 — FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM (October 15, 1991)
  • K911445 — FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM (June 28, 1991)
  • K904340 — FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM (October 19, 1990)

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)
  • 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)