Panels › Orthopedic › Product code HTW · Class 1
Bit, Drill
Regulation 888.4540
0510(k)s in 12 months (11 all time)
2recalls in 12 months (114 all time)
12recalls that name a 510(k)
Top companies in HTW
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 0 | 60 |
| Stryker Howmedica Osteonics | 0 | 8 |
| Exactech, Inc. | 0 | 6 |
| Flower Orthopedics Corporation | 0 | 4 |
| Waldemar Link GmbH & Co. KG (Mfg Site) | 0 | 4 |
| AAP Implantate Ag | 0 | 2 |
| The Anspach Effort, Inc. | 0 | 2 |
| Biomet, Inc. | 0 | 2 |
| Intelifuse Inc | 0 | 2 |
| Interventional Spine Inc | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2016 | K151661 | Renovo Life Hard Carbon Coated Drill Bit Renovo Life, LLC | HTW |
| Dec 22, 1994 | K942906 | AGEE-WRISTJACK PRE-DRILL KIT Hand Biomechanics Lab, Inc. | HTW |
| Aug 6, 1993 | K930339 | REAMER BIT Neoligaments, Ltd., GB | HTW |
| Jan 16, 1992 | K915692 | CANNULATED DRILL BIT W. L. Gore & Associates, Inc. | HTW |
| Oct 6, 1989 | K892903 | MITEK ANCHOR DRILL Mitek Surgical Products, Inc. | HTW |
| Feb 6, 1987 | K870217 | FEMORAL CEMENT REMOVAL INSTRUMENTS Kenneth J. Hoek, M.D., Inc. | HTW |
| Sep 5, 1986 | K863147 | GLENOID DRILL Bowen & Company, Inc. | HTW |
| Aug 27, 1984 | K841629 | DRILL BIT Plastafil, Inc. | HTW |
| Jan 10, 1984 | K834229 | BONE PLUGGING TOOL Standard Surgical | HTW |
| Jul 7, 1983 | K831712 | SURGICAL DRILL BITS Medical Specialists IN Packaging | HTW |
| Feb 4, 1982 | K820226 | UNIVERSALL DRILL GUIDE Ortho Pared Instruments, Inc. | HTW |
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