Drill Bit
FDA 510(k) K841629 · Plastafil, Inc.
510(k) numberK841629
Submission
- Device name
- Drill Bit
- Applicant
- Plastafil, Inc.
Mchenry, IL, US - Received
- April 19, 1984
- Decision date
- August 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTW – Bit, Drill
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill BitHTW · Traditional | Renovo Life, LLC | 01/15/2016SE |
| K942906 | Agee-Wristjack Pre-Drill KitHTW · Traditional | Hand Biomechanics Lab, Inc. | 12/22/1994SE |
| K930339 | Reamer BitHTW · Traditional | Neoligaments, Ltd. | 08/06/1993SE |
| K915692 | Cannulated Drill BitHTW · Traditional | W. L. Gore & Associates, Inc. | 01/16/1992SE |
| K892903 | Mitek Anchor DrillHTW · Traditional | Mitek Surgical Products, Inc. | 10/06/1989SE |
| K870217 | Femoral Cement Removal InstrumentsHTW · Traditional | Kenneth J. Hoek, M.D., Inc. | 02/06/1987SE |
| K863147 | Glenoid DrillHTW · Traditional | Bowen & Company, Inc. | 09/05/1986SE |
| K834229 | Bone Plugging ToolHTW · Traditional | Standard Surgical | 01/10/1984SE |
| K831712 | Surgical Drill BitsHTW · Traditional | Medical Specialists IN Packaging | 07/07/1983SE |
| K820226 | Universall Drill GuideHTW · Traditional | Ortho Pared Instruments, Inc. | 02/04/1982SE |
More from Ortho Pared Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841621 | Back Radius CutterHTX · Traditional | 09/20/1984SE |
| K841620 | Front Radius CutterHTX · Traditional | 09/20/1984SE |
| K841627 | MalletHWA · Traditional | 08/27/1984SE |
| K841626 | PunchHXG · Traditional | 08/27/1984SE |
| K841625 | HookGAD · Traditional | 08/27/1984SE |
| K841624 | ProbeHRX · Traditional | 08/27/1984SE |
| K841618 | Threading TubeFZX · Traditional | 08/27/1984SE |
| K841617 | Strover HookHCF · Traditional | 08/27/1984SE |
| K841628 | WireHXN · Traditional | 07/23/1984SE |
| K841623 | Slotted Soft-Tissue InstrumentHWQ · Traditional | 07/11/1984SE |
Questions and answers
When was Drill Bit cleared by the FDA?
Drill Bit (K841629) received a 510(k) decision of Substantially Equivalent on August 27, 1984, 130 days after the submission was received.
What is the product code of K841629?
The FDA product code is HTW – Bit, Drill, a Class I (low risk) device regulated under 21 CFR 888.4540.