Techmedica Drill Guide
FDA 510(k) K841297 · Techmedica, Inc.
510(k) numberK841297
Submission
- Device name
- Techmedica Drill Guide
- 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
- FZX – Guide, Surgical, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914715 | Paralleling GuidesFZX · Traditional | Implant Corp. of America | 02/16/1994SE |
| K871413 | Civco StepperFZX · Traditional | CIVCO Medical Instruments Co., Inc. | 07/14/1987SE |
| K871503 | Biopsy Needle Guide Kit, SterileFZX · Traditional | Amedic USA | 07/10/1987SE |
| K862564 | A.C.L. Guide KitFZX · Traditional | Aspen Laboratories, Inc. | 08/18/1986SE |
| K854262 | Meadox Surgimed Breast Localization Wire Set/OnlyFZX · Traditional | Meadox Surgimed, Inc. | 12/24/1985SE |
| K852402 | Namic Homer Mammalok Needle/Wire LocalizerFZX · Traditional | North American Instrument Corp. | 07/11/1985SE |
| K842698 | British Spinal Fusion SetFZX · Traditional | Downs Surgical , Ltd. | 09/12/1984SE |
| K841618 | Threading TubeFZX · Traditional | Plastafil, Inc. | 08/27/1984SE |
| K841619 | Drill GuideFZX · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K840835 | Straith Drain InserterFZX · Traditional | Surgical Technology Laboratories, Inc. | 04/23/1984SE |
More from Surgical Technology Laboratories, Inc.
| 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 Techmedica Drill Guide cleared by the FDA?
Techmedica Drill Guide (K841297) 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 K841297?
The FDA product code is FZX – Guide, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.