Laure Wrist Implant
FDA 510(k) K803031 · Laure Prosthetics, Inc.
510(k) numberK803031
Submission
- Device name
- Laure Wrist Implant
- Applicant
- Laure Prosthetics, Inc.
Mchenry, IL, US - Received
- November 28, 1980
- Decision date
- June 29, 1982
- 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 |
| K800602 | Taleisnik Total Wrist ProsthesisKWM · Traditional | Dow Corning Wright | 08/27/1980SE |
| K801157 | Weber-Mayo WristKWM · Traditional | Depuy, Inc. | 08/04/1980SE |
| K790774 | Loda Wrist ProsthesisKWM · Traditional | Depuy, Inc. | 08/03/1979SE |
Questions and answers
When was Laure Wrist Implant cleared by the FDA?
Laure Wrist Implant (K803031) received a 510(k) decision of Substantially Equivalent on June 29, 1982, 578 days after the submission was received.
What is the product code of K803031?
The FDA product code is KWM – Prosthesis, Wrist, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3800.