Front Radius Cutter
FDA 510(k) K841620 · Plastafil, Inc.
510(k) numberK841620
Submission
- Device name
- Front Radius Cutter
- Applicant
- Plastafil, Inc.
Mchenry, IL, US - Received
- April 19, 1984
- Decision date
- September 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTX – Rongeur
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874954 | Manual RongeurHTX · Traditional | Solway, Inc. | 12/30/1987SE |
| K841621 | Back Radius CutterHTX · Traditional | Plastafil, Inc. | 09/20/1984SE |
| K780397 | Orthopedic ForcepsHTX · Traditional | Orthopedic Equipment Co., Inc. | 03/22/1978SE |
| K760325 | Surgical Instruments, OrthopedicHTX · Traditional | Depuy, Inc. | 08/03/1976SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841621 | Back Radius CutterHTX · Traditional | 09/20/1984SE |
| K841629 | Drill BitHTW · Traditional | 08/27/1984SE |
| 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 Front Radius Cutter cleared by the FDA?
Front Radius Cutter (K841620) received a 510(k) decision of Substantially Equivalent on September 20, 1984, 154 days after the submission was received.
What is the product code of K841620?
The FDA product code is HTX – Rongeur, a Class I (low risk) device regulated under 21 CFR 888.4540.