RMC Total Knee System
FDA 510(k) K823837 · Richard'S Medical Equip., Inc.
510(k) numberK823837
Submission
- Device name
- RMC Total Knee System
- Applicant
- Richard'S Medical Equip., Inc.
Walker, MI, US - Received
- December 21, 1982
- Decision date
- March 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MBV – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010212 | Offset Tibial TrayMBV · Special | Biomet, Inc. | 02/14/2001SE |
| K884824 | Tricon-M Total Knee SystemMBV · Traditional | Richards Medical Co., Inc. | 11/21/1989SN |
| K873429 | Freeman-Samuelson Mark II Press-Fit Total KneeMBV · Traditional | Protek, Inc. | 10/28/1987SE |
| K853730 | Freeman-Samuelson Mark II Press-Fit Total Knee RepMBV · Traditional | Protek, Inc. | 02/18/1986SE |
| K833200 | Tricon M Total Knee SystemMBV · Traditional | Richards Medical Co., Inc. | 11/29/1983SE |
| K831441 | Porocoat Freeman/Samuelson Total KneeMBV · Traditional | Depuy, Inc. | 09/01/1983SE |
| K832302 | Mark I Total Knee Sys. ArthroplastyMBV · Traditional | Advanced Biosearch Assn. | 08/16/1983SE |
| K830726 | Mark I & II Total Knee Replace. SysMBV · Traditional | Advanced Biosearch Assn. | 06/22/1983SE |
| K830408 | Freeman/Samuelson Total KneeMBV · Traditional | Depuy, Inc. | 02/24/1983SE |
| K822583 | Total Knee SystemMBV · Traditional | Richard'S Medical Equip., Inc. | 10/04/1982SE |
More from Richard'S Medical Equip., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830793 | Patient Guided Elbow & Shoulder ExercBXB · Traditional | 06/16/1983SE |
| K823726 | Spectron Conversion Endoprosthesis CupKWY · Traditional | 03/09/1983SE |
| K823724 | Spectron Neck Replacement ProsthesisJDI · Traditional | 03/09/1983SE |
| K823723 | Spectron Proximal Femoral ProsthesisJDI · Traditional | 03/09/1983SE |
| K823727 | Spectron Primary Stem Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K823722 | Spectron Long, Straight Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K830153 | Richards Intra-Articular Shaver BladesGEY · Traditional | 02/28/1983SE |
| K830154 | Colles Fracture FrameJEC · Traditional | 02/02/1983SE |
| K823729 | Spectron Metal Back Acetabular ComponentJDI · Traditional | 01/21/1983SE |
| K823728 | Spectron Polyethylene Acctubular ComponJDI · Traditional | 01/21/1983SE |
Questions and answers
When was RMC Total Knee System cleared by the FDA?
RMC Total Knee System (K823837) received a 510(k) decision of Substantially Equivalent on March 29, 1983, 98 days after the submission was received.
What is the product code of K823837?
The FDA product code is MBV – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.