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510(k) K935753

THE GRAFTOLOGER by Neoligaments, Ltd. — Product Code HWE

K935753 is an FDA 510(k) premarket notification submitted by Neoligaments, Ltd. for the device "THE GRAFTOLOGER". The FDA issued a decision of Substantially Equivalent on April 25, 1994. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Neoligaments, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1994
Date Received
November 26, 1993
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)
  • K952543 — GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET (June 22, 1995)
  • 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)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)

FDA data resources