HTW · Class I · 21 CFR 888.4540

FDA Product Code HTW: Bit, Drill

Leading manufacturers include Mitek Surgical Products, Inc., W.L. Gore & Associates, Inc. and Renovo Life, LLC.

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 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

About Product Code HTW - Regulatory Context