Reflection Dual Dimension Shell
FDA 510(k) K960094 · Smith & Nephew Richards, Inc.
510(k) numberK960094
Submission
- Device name
- Reflection Dual Dimension Shell
- Applicant
- Smith & Nephew Richards, Inc.
Memphis, TN, US - Received
- January 11, 1996
- Decision date
- March 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201157 | Prime BIOFOAM® Multi-Hole ShellsMBL · Traditional | Microport Orthopedics, Inc. | 08/24/2021SE |
| K201701 | R3 HA Coated Acetabular ShellsMBL · Traditional | Smith & Nephew, Inc. | 10/06/2020SE |
| K182535 | R3 Anteverted LinersMBL · Special | Smith & Nephew, Inc. | 11/19/2018SE |
| K161233 | OXINIUM DH Fermoral HeadsMBL · Traditional | Smith & Nephew, Inc. | 12/14/2016SE |
| K122382 | Dynasty Biofoam ShellMBL · Special | Wrightmedicaltechnologyinc | 10/22/2012SE |
| K113848 | R3 Xlpe LinersMBL · Traditional | Smith & Nephew, Inc. | 04/27/2012SE |
| K102370 | R3 Xlpe Anteverted LinersMBL · Abbreviated | Smith & Nephew, Inc. | 01/19/2011SE |
| K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe LinersMBL · Traditional | Smith & Nephew, Inc. | 01/26/2010SE |
| K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersMBL · Abbreviated | Smith & Nephew, Inc. | 11/03/2009SE |
| K070756 | Smith and Nephew Reflection 3 Acetabular SystemMBL · Special | Smith & Nephew, Inc. | 06/06/2007SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K965224 | Empower Anterior Direct ScrewsKWP · Traditional | 05/08/1997SE |
| K963509 | Global Taper Tapered Hip System, GT SpectronLPH · Traditional | 01/27/1997SE |
| 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 |
| K962541 | Reflection Acetabular Reinforcement RingsJDJ · Traditional | 09/17/1996SE |
| 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 |
Questions and answers
When was Reflection Dual Dimension Shell cleared by the FDA?
Reflection Dual Dimension Shell (K960094) received a 510(k) decision of Substantially Equivalent on March 27, 1996, 76 days after the submission was received.
What is the product code of K960094?
The FDA product code is MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous, a Class II (moderate risk) device regulated under 21 CFR 888.3358.