Techmedica Mueller Type Polyethylene Acetbul Cup
FDA 510(k) K925181 · Techmedica, Inc.
510(k) numberK925181
Submission
- Device name
- Techmedica Mueller Type Polyethylene Acetbul Cup
- Applicant
- Techmedica, Inc.
Camarillo, CA, US - Received
- October 14, 1992
- Decision date
- February 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 888.3320
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesJDL · Traditional | Zimmer, Inc. | 08/07/2008SE |
| K070785 | Dynasty Acetabular SystemJDL · Special | Wrightmedicaltechnologyinc | 07/11/2007SE |
| K061844 | Dynasty Acetabular Shell and Cocr Acetabular LinerJDL · Special | Wrightmedicaltechnologyinc | 12/06/2006SE |
| K051995 | Profemur Renaissance Hip StemJDL · Special | Wrightmedicaltechnologyinc | 08/22/2005SE |
| K051348 | Conserve Total Femoral HeadJDL · Traditional | Wrightmedicaltechnologyinc | 08/19/2005SE |
| K042841 | M2A/C2A Acetabular SystemJDL · Traditional | Biomet, Inc. | 12/21/2004SE |
| K041586 | Profemur S Hip StemJDL · Special | Wrightmedicaltechnologyinc | 07/09/2004SE |
| K041114 | Profemur Tapered Hip StemJDL · Special | Wrightmedicaltechnologyinc | 05/28/2004SE |
| K004043 | Metal Transcend Articulation SystemJDL · Abbreviated | Wrightmedicaltechnologyinc | 07/13/2001SE |
| K950542 | Metal Backed Acetabular ComponentJDL · Traditional | Encore Orthopedics, Inc. | 05/25/1995SE |
More from Encore Orthopedics, 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 |
| K920080 | Continuum Knee SystemJWH · Traditional | 09/01/1992SN |
| K921458 | TMP Microplating SystemHRS · Traditional | 07/17/1992SE |
Questions and answers
When was Techmedica Mueller Type Polyethylene Acetbul Cup cleared by the FDA?
Techmedica Mueller Type Polyethylene Acetbul Cup (K925181) received a 510(k) decision of Substantially Equivalent on February 5, 1993, 114 days after the submission was received.
What is the product code of K925181?
The FDA product code is JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3320.