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510(k) K930339

REAMER BIT by Neoligaments, Ltd. — Product Code HTW

K930339 is an FDA 510(k) premarket notification submitted by Neoligaments, Ltd. for the device "REAMER BIT". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code HTW (Bit, Drill), a Class I device regulated under 21 CFR 888.4540. Neoligaments, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
January 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bit, Drill
Device Class
Class I
Regulation Number
888.4540
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)
  • K935753 — THE GRAFTOLOGER (April 25, 1994)
  • 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 HTW

  • K151661 — Renovo Life Hard Carbon Coated Drill Bit (January 15, 2016)
  • K942906 — AGEE-WRISTJACK PRE-DRILL KIT (December 22, 1994)
  • K915692 — CANNULATED DRILL BIT (January 16, 1992)
  • K892903 — MITEK ANCHOR DRILL (October 6, 1989)
  • K870217 — FEMORAL CEMENT REMOVAL INSTRUMENTS (February 6, 1987)
  • K863147 — GLENOID DRILL (September 5, 1986)
  • K841629 — DRILL BIT (August 27, 1984)
  • K834229 — BONE PLUGGING TOOL (January 10, 1984)
  • K831712 — SURGICAL DRILL BITS (July 7, 1983)
  • K820226 — UNIVERSALL DRILL GUIDE (February 4, 1982)

FDA data resources