FDA Product Code
FDA Product Code HTW — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.4540
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill Bit | Renovo Life, LLC | 2016-01-15 | Traditional | PDF ↗ |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Hand Biomechanics Lab, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K930339 | REAMER BIT | Neoligaments, Ltd. | 1993-08-06 | Traditional | PDF ↗ |
| K915692 | CANNULATED DRILL BIT | W. L. Gore & Associates, Inc. | 1992-01-16 | Traditional | PDF ↗ |
| K892903 | MITEK ANCHOR DRILL | Mitek Surgical Products, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K870217 | FEMORAL CEMENT REMOVAL INSTRUMENTS | Kenneth J. Hoek, M.D., Inc. | 1987-02-06 | Traditional | PDF ↗ |
| K863147 | GLENOID DRILL | Bowen & Company, Inc. | 1986-09-05 | Traditional | PDF ↗ |
| K841629 | DRILL BIT | Plastafil, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K834229 | BONE PLUGGING TOOL | Standard Surgical | 1984-01-10 | Traditional | PDF ↗ |
| K831712 | SURGICAL DRILL BITS | Medical Specialists IN Packaging | 1983-07-07 | Traditional | PDF ↗ |
| K820226 | UNIVERSALL DRILL GUIDE | Ortho Pared Instruments, Inc. | 1982-02-04 | Traditional | PDF ↗ |
Product code HTW · Class I · Orthopedic. Data: openFDA.