Freeman/Samuelson Total Knee
FDA 510(k) K830408 · Depuy, Inc.
510(k) numberK830408
Submission
- Device name
- Freeman/Samuelson Total Knee
- Applicant
- Depuy, Inc.
Walker, MI, US - Received
- February 7, 1983
- Decision date
- February 24, 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 |
| K823837 | RMC Total Knee SystemMBV · Traditional | Richard'S Medical Equip., Inc. | 03/29/1983SE |
| K822583 | Total Knee SystemMBV · Traditional | Richard'S Medical Equip., Inc. | 10/04/1982SE |
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| K033959 | LPSJWH · Traditional | 07/01/2004SE |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
| K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional | 09/07/2001SE |
Questions and answers
When was Freeman/Samuelson Total Knee cleared by the FDA?
Freeman/Samuelson Total Knee (K830408) received a 510(k) decision of Substantially Equivalent on February 24, 1983, 17 days after the submission was received.
What is the product code of K830408?
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.