Product code HTW
- Device name
- Bit, Drill
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill Bit | Renovo Life, LLC | 2016-01-15 |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Hand Biomechanics Lab, Inc. | 1994-12-22 |
| K930339 | REAMER BIT | Neoligaments, Ltd. | 1993-08-06 |
| K915692 | CANNULATED DRILL BIT | W. L. Gore & Associates, Inc. | 1992-01-16 |
| K892903 | MITEK ANCHOR DRILL | Mitek Surgical Products, Inc. | 1989-10-06 |
| K870217 | FEMORAL CEMENT REMOVAL INSTRUMENTS | Kenneth J. Hoek, M.D., Inc. | 1987-02-06 |
| K863147 | GLENOID DRILL | Bowen & Company, Inc. | 1986-09-05 |
| K841629 | DRILL BIT | Plastafil, Inc. | 1984-08-27 |
| K834229 | BONE PLUGGING TOOL | Standard Surgical | 1984-01-10 |
| K831712 | SURGICAL DRILL BITS | Medical Specialists IN Packaging | 1983-07-07 |
| K820226 | UNIVERSALL DRILL GUIDE | Ortho Pared Instruments, Inc. | 1982-02-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840606191807 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191814 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191821 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191852 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606195768 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606195775 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191791 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00190376544472 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544878 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544861 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544489 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544465 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544458 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544434 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544427 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544410 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544403 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544397 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 00190376544441 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 03701089528047 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089529976 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089528351 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089528344 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089526579 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089515153 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03700569674359 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-28 |
| 03700569674366 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-28 |
| 03700569674700 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-28 |
| 03700569679194 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-28 |
| 03700569680220 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-28 |