Natural Lock Acetabular Component
FDA 510(k) K830662 · Advanced Biosearch Assn.
510(k) numberK830662
Submission
- Device name
- Natural Lock Acetabular Component
- Applicant
- Advanced Biosearch Assn.
Walker, MI, US - Received
- March 3, 1983
- Decision date
- April 11, 1983
- 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 |
|---|---|---|
| K905514 | Autogenesis(Tm) AutomatorKTT · Traditional | 04/02/1991SE |
| K883888 | Cathscanner Intravascular Ultrasonic Imaging Syst.DXK · Traditional | 12/12/1988SE |
| K854770 | Martin Laminar Osteosynthesis SystemKWP · Traditional | 02/11/1986SE |
| K855030 | Champy Bone Plates & Bone ScrewsJEY · Traditional | 01/30/1986SE |
| K855031 | Manual Surgical Instruments & Access.Champy Bone PHWC · Traditional | 01/21/1986SE |
| K853916 | P.M. Hip-Femoral ProsthesisJDI · Traditional | 12/27/1985SE |
| K852839 | Freeman HipJDI · Traditional | 10/29/1985SE |
| K853418 | Safti-BraceletKMK · Traditional | 09/20/1985SE |
| K852517 | CLS Hip ProsthesisJDI · Traditional | 09/18/1985SE |
| K852699 | Freeman Acetabular CupKWA · Traditional | 09/05/1985SE |
Questions and answers
When was Natural Lock Acetabular Component cleared by the FDA?
Natural Lock Acetabular Component (K830662) received a 510(k) decision of Substantially Equivalent on April 11, 1983, 39 days after the submission was received.
What is the product code of K830662?
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.