Maestro Carpal Hemiarthroplasty
FDA 510(k) K050028 · Biomet Manufacturing, Inc.
510(k) numberK050028
Submission
- Device name
- Maestro Carpal Hemiarthroplasty
- Applicant
- Biomet Manufacturing, Inc.
Warsaw, IN, US - Received
- January 6, 2005
- Decision date
- March 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWN – Prosthesis, Wrist, Carpal Lunate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3750
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141920 | Wrist Hemiarthroplasty SystemKWN · Traditional | Arthrosurface, Inc. | 12/23/2014SE |
| K080997 | Ascension Pyrocarbon LunateKWN · Traditional | Ascension Orthopedics, Inc. | 06/17/2008SE |
| K864491 | Swanson Titanium Carpal Lunate ImplantKWN · Traditional | Dow Corning Wright | 04/15/1987SE |
| K790793 | Amc R Metacarpal ComponentKWN · Traditional | Howmedica Corp. | 06/22/1979SE |
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| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | 02/17/2017SE |
Questions and answers
When was Maestro Carpal Hemiarthroplasty cleared by the FDA?
Maestro Carpal Hemiarthroplasty (K050028) received a 510(k) decision of Substantially Equivalent on March 25, 2005, 78 days after the submission was received.
What is the product code of K050028?
The FDA product code is KWN – Prosthesis, Wrist, Carpal Lunate, a Class II (moderate risk) device regulated under 21 CFR 888.3750.