HTW · Class I · 21 CFR 888.4540

FDA Product Code HTW: Bit, Drill

Leading manufacturers include W.L. Gore & Associates, Inc., Neoligaments, Ltd. and Hand Biomechanics Lab, Inc..

11
Total
11
Cleared
94d
Avg days
1982
Since

FDA 510(k) Cleared Bit, Drill Devices (Product Code HTW)

11 devices
1–11 of 11
Cleared Jan 15, 2016
Renovo Life Hard Carbon Coated Drill Bit
K151661
Renovo Life, LLC
Orthopedic · 210d
Cleared Dec 22, 1994
AGEE-WRISTJACK PRE-DRILL KIT
K942906
Hand Biomechanics Lab, Inc.
Orthopedic · 184d
Cleared Aug 06, 1993
REAMER BIT
K930339
Neoligaments, Ltd.
Orthopedic · 193d
Cleared Jan 16, 1992
CANNULATED DRILL BIT
K915692
W.L. Gore & Associates, Inc.
Orthopedic · 24d
Cleared Oct 06, 1989
MITEK ANCHOR DRILL
K892903
Mitek Surgical Products, Inc.
Orthopedic · 169d
Cleared Feb 06, 1987
FEMORAL CEMENT REMOVAL INSTRUMENTS
K870217
Kenneth J. Hoek, M.D., Inc.
Orthopedic · 16d
Cleared Sep 05, 1986
GLENOID DRILL
K863147
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Aug 27, 1984
DRILL BIT
K841629
Plastafil, Inc.
Orthopedic · 130d
Cleared Jan 10, 1984
BONE PLUGGING TOOL
K834229
Standard Surgical
Orthopedic · 35d
Cleared Jul 07, 1983
SURGICAL DRILL BITS
K831712
Medical Specialists IN Packaging
Orthopedic · 41d
Cleared Feb 04, 1982
UNIVERSALL DRILL GUIDE
K820226
Ortho Pared Instruments, Inc.
Orthopedic · 8d

About Product Code HTW - Regulatory Context