Hole Chamfering Device
FDA 510(k) K841298 · Techmedica, Inc.
510(k) numberK841298
Submission
- Device name
- Hole Chamfering Device
- Applicant
- Techmedica, Inc.
Mchenry, IL, US - Received
- March 30, 1984
- Decision date
- April 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFF – Bur, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K974025 | Anspach Shielded AttachmentGFF · Traditional | The Anspach Effort, Inc. | 07/06/1998SE |
| K950449 | Surgical BurGFF · Traditional | Transidyne General Corp. | 03/01/1995SE |
| K943758 | Surgical BurGFF · Traditional | Komet Medical | 08/22/1994SE |
| K934583 | BurrsGFF · Traditional | American Medical Specialties, Inc. | 01/26/1994SE |
| K894438 | Micro-Aire Cutters for Midas-Rex InstrumentsGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 08/21/1989SE |
| K890090 | Danek Irrigating Burr (Dib) SetGFF · Traditional | Danek Medical, Inc. | 01/24/1989SE |
| K883255 | Komet Surgical BurGFF · Traditional | Komet Medical, Div. of Brasseler USA I, L.P. | 09/15/1988SE |
| K880859 | Surgical BursGFF · Traditional | New England Surgical Instrument Corp. | 03/21/1988SE |
| K880706 | Surgical BursGFF · Traditional | Nuell Air Equipment & Hospital Supplies, Inc. | 02/26/1988SE |
| K872475 | Surgical BurGFF · Traditional | Tava Surgical Instruments | 07/02/1987SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K933935 | CKS Porous Coated Femoral ComponentHRY · Traditional | 10/11/1994SE |
| K932017 | Techmedica Continuum Hip with Ha CoatingMEH · Traditional | 09/01/1994SE |
| K931929 | Techmedica Continuum Hip SystemLZO · Traditional | 03/29/1994SE |
| K926387 | Techmedica Standard Cemented Hip SystemKWY · Traditional | 02/01/1994SE |
| K925420 | Techmedica Standard Bipolar SystemKWY · Traditional | 09/28/1993SE |
| K923808 | Muller Straight Stem Femoral ProsthesisLZO · Traditional | 07/27/1993SE |
| K926579 | Techmedica 6.5MM Self-Tapping Cancellous Bone ScreHWC · Traditional | 04/06/1993SE |
| K911058 | Techmedica Cad/Cam Custom HipJDI · Traditional | 02/23/1993SE |
| K925181 | Techmedica Mueller Type Polyethylene Acetbul CupJDL · Traditional | 02/05/1993SE |
| K920080 | Continuum Knee SystemJWH · Traditional | 09/01/1992SN |
Questions and answers
When was Hole Chamfering Device cleared by the FDA?
Hole Chamfering Device (K841298) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 26 days after the submission was received.
What is the product code of K841298?
The FDA product code is GFF – Bur, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4820.