Loda Wrist Prosthesis
FDA 510(k) K790774 · Depuy, Inc.
510(k) numberK790774
Submission
- Device name
- Loda Wrist Prosthesis
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- April 20, 1979
- Decision date
- August 3, 1979
- 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 |
| K801157 | Weber-Mayo WristKWM · Traditional | Depuy, Inc. | 08/04/1980SE |
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| 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 |
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Questions and answers
When was Loda Wrist Prosthesis cleared by the FDA?
Loda Wrist Prosthesis (K790774) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 105 days after the submission was received.
What is the product code of K790774?
The FDA product code is KWM – Prosthesis, Wrist, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3800.