Weber-Mayo Wrist
FDA 510(k) K801157 · Depuy, Inc.
510(k) numberK801157
Submission
- Device name
- Weber-Mayo Wrist
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- May 14, 1980
- Decision date
- August 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWM – Prosthesis, Wrist, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3800
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880156 | Volz Total Wrist ProsthesisKWM · Traditional | Biomet, Inc. | 02/17/1988SE |
| K872502 | M.W.P. Wrist ProsthesisKWM · Traditional | Protek, Inc. | 07/23/1987SE |
| K803031 | Laure Wrist ImplantKWM · Traditional | Laure Prosthetics, Inc. | 06/29/1982SE |
| K800602 | Taleisnik Total Wrist ProsthesisKWM · Traditional | Dow Corning Wright | 08/27/1980SE |
| K790774 | Loda Wrist ProsthesisKWM · Traditional | Depuy, Inc. | 08/03/1979SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043058 | Pinnacle Constrained Acetabular LinersKWZ · Traditional | 03/14/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | 12/08/2004SE |
| K041085 | LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryJWH · Traditional | 07/22/2004SE |
| 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 Weber-Mayo Wrist cleared by the FDA?
Weber-Mayo Wrist (K801157) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 82 days after the submission was received.
What is the product code of K801157?
The FDA product code is KWM – Prosthesis, Wrist, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3800.