Techmedica I.B.O. Blade
FDA 510(k) K883922 · Techmedica, Inc.
510(k) numberK883922
Submission
- Device name
- Techmedica I.B.O. Blade
- Applicant
- Techmedica, Inc.
Camarillo, CA, US - Received
- September 16, 1988
- Decision date
- December 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Centermed, 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 I.B.O. Blade cleared by the FDA?
Techmedica I.B.O. Blade (K883922) received a 510(k) decision of Substantially Equivalent on December 8, 1988, 83 days after the submission was received.
What is the product code of K883922?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.