Link Metal-Backed Acetabular Cups
FDA 510(k) K854935 · Link America, Inc.
510(k) numberK854935
Submission
- Device name
- Link Metal-Backed Acetabular Cups
- Applicant
- Link America, Inc.
East Hanavor, NJ, US - Received
- December 10, 1985
- Decision date
- March 5, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K972760 | Link, Acetabular Revision Mesh CupJDJ · Traditional | 10/22/1997SE |
| K964458 | Ellis External Mini-Fixator SystemKTT · Traditional | 12/09/1996SE |
| K955296 | Link MP Reconstruction HipJDI · Traditional | 02/14/1996SE |
| K954186 | Sled Unicompartment Knee SystemHSX · Traditional | 01/26/1996SE |
| K931571 | Link Ceramic Heads 12/14 X 32MMLZO · Traditional | 04/19/1994SN |
| K931572 | Link Ceramic Heads 14/16 X 32MMLZO · Traditional | 03/28/1994SE |
| K920756 | Feldmuhle Ceramic HeadLZO · Traditional | 05/18/1992SE |
| K914804 | Radius Osteotomy PlatesHRS · Traditional | 04/29/1992SN |
| K914803 | Schwabe Radius PlatesHRS · Traditional | 04/28/1992SE |
| K895507 | Link Giebel Blade Plate SystemKTT · Traditional | 03/13/1990SE |
Questions and answers
When was Link Metal-Backed Acetabular Cups cleared by the FDA?
Link Metal-Backed Acetabular Cups (K854935) received a 510(k) decision of Substantially Equivalent on March 5, 1986, 85 days after the submission was received.
What is the product code of K854935?
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.