Reflection Acetabular Reinforcement Rings
FDA 510(k) K962541 · Smith & Nephew Richards, Inc.
510(k) numberK962541
Submission
- Device name
- Reflection Acetabular Reinforcement Rings
- Applicant
- Smith & Nephew Richards, Inc.
Memphis, TN, US - Received
- June 28, 1996
- Decision date
- September 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDJ – Mesh, Surgical, Acetabular, Hip, Prosthesis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code JDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972760 | Link, Acetabular Revision Mesh CupJDJ · Traditional | Link America, Inc. | 10/22/1997SE |
| K970957 | Osteonics Restoration Acetabular RingJDJ · Traditional | Osteonics Corp. | 06/03/1997SE |
| K963940 | Exeter MeshJDJ · Traditional | Howmedica, Inc. | 02/13/1997SE |
| K962007 | Protrusion CagesJDJ · Traditional | Depuy, Inc. | 08/01/1996SE |
| K925883 | Osteonics Microstructured Acetabular ComponentsJDJ · Traditional | Osteonics Corp. | 06/15/1993SE |
| K890450 | Intermedics Apr(Tm) II Femoral ComponentJDJ · Traditional | Intermedics Orthopedics | 08/09/1989SN |
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| K960444 | Finn Rod to Rod ConnectorKWP · Traditional | 01/24/1997SE |
| K964163 | Trimax Nail SystemHSB · Traditional | 12/27/1996SE |
| K962557 | Genesis II Zirconium Femoral Component/Profix Zirconium Femoral ComponentJWH · Traditional | 12/05/1996SN |
| K963486 | Revision Hip SystemJDI · Traditional | 11/27/1996SE |
| K962808 | Ilizarov External Fixation SystemKTT · Traditional | 08/19/1996SE |
| K962137 | Genesis II Constrained SystemJWH · Traditional | 08/02/1996SE |
| K955767 | Cofied Modular Shoulder SystemKWS · Traditional | 04/08/1996SN |
| K960094 | Reflection Dual Dimension ShellMBL · Traditional | 03/27/1996SE |
Questions and answers
When was Reflection Acetabular Reinforcement Rings cleared by the FDA?
Reflection Acetabular Reinforcement Rings (K962541) received a 510(k) decision of Substantially Equivalent on September 17, 1996, 81 days after the submission was received.
What is the product code of K962541?
The FDA product code is JDJ – Mesh, Surgical, Acetabular, Hip, Prosthesis, a Class II (moderate risk) device regulated under 21 CFR 878.3300.