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510(k) K942906

AGEE-WRISTJACK PRE-DRILL KIT by Hand Biomechanics Lab, Inc. — Product Code HTW

K942906 is an FDA 510(k) premarket notification submitted by Hand Biomechanics Lab, Inc. for the device "AGEE-WRISTJACK PRE-DRILL KIT". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code HTW (Bit, Drill), a Class I device regulated under 21 CFR 888.4540. Hand Biomechanics Lab, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1994
Date Received
June 21, 1994
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 Hand Biomechanics Lab, Inc.

  • K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
  • K222490 — HBL Blade Assembly (November 14, 2022)
  • K181192 — PIP Fix (October 22, 2018)
  • K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (January 9, 2008)
  • K033112 — WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-3 (November 5, 2003)
  • K030519 — WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, C (June 10, 2003)
  • K992970 — DIGIT WIDGET (November 8, 1999)
  • K984442 — AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 (February 12, 1999)

Other clearances for product code HTW

  • K151661 — Renovo Life Hard Carbon Coated Drill Bit (January 15, 2016)
  • K930339 — REAMER BIT (August 6, 1993)
  • 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