Ascension Muh
FDA 510(k) K052137 · Ascension Orthopedics, Inc.
510(k) numberK052137
Submission
- Device name
- Ascension Muh
- Applicant
- Ascension Orthopedics, Inc.
Austin, TX, US - Received
- August 5, 2005
- Decision date
- November 3, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KXE – Prosthesis, Wrist, Hemi-, Ulnar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3810
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 05/03/2019SE |
| K142569 | Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 04/03/2015SE |
| K112481 | First Choice Druj System, Partial Head ImplantKXE · Traditional | Ascension Orthopedic | 04/09/2012SE |
| K081025 | IsoelasticuKXE · Traditional | Remi Sciences, Inc. | 11/21/2008SE |
| K082839 | Distal Radio-Ulnar Joint ImplantKXE · Special | Aptis Medical, LLC | 10/24/2008SE |
| K061146 | Sbi Ulnar Head ImplantKXE · Special | Small Bone Innovations, Inc. | 07/19/2006SE |
| K053119 | Distal Radio-Ulnar Joint ImplantKXE · Special | Aptis Medical, LLC | 12/07/2005SE |
| K040497 | Distal Radio-Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 01/26/2005SE |
| K042902 | Herbert Ulnar Head Prosthesis SystemKXE · Traditional | Stuckenbrock Medizintechnik GmbH | 12/27/2004SE |
| K033930 | Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional | Kapp Surgical Instrument, Inc. | 07/28/2004SE |
More from Kapp Surgical Instrument, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233674 | Freedom Wrist Arthroplasty SystemJWJ · Traditional | 05/30/2024SE |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIPKYJ · Special | 12/14/2023SE |
| K182878 | Integra Salto Total Ankle SystemHSN · Special | 12/18/2018SE |
| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation SystemHWC · Traditional | 07/14/2017SE |
| K160830 | Integra External Fixation SystemKTT · Special | 07/06/2016SE |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS · Traditional | 12/23/2015SE |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC · Traditional | 10/29/2015SE |
| K151459 | Integra Total Ankle Replacement SystemHSN · Traditional | 08/31/2015SE |
| K142413 | TITAN Modular Total Shoulder SystemKWS · Traditional | 11/14/2014SE |
| K121826 | Integra Proximal Humeral Plate SystemHRS · Traditional | 02/13/2013SE |
Questions and answers
When was Ascension Muh cleared by the FDA?
Ascension Muh (K052137) received a 510(k) decision of Substantially Equivalent on November 3, 2005, 90 days after the submission was received.
What is the product code of K052137?
The FDA product code is KXE – Prosthesis, Wrist, Hemi-, Ulnar, a Class II (moderate risk) device regulated under 21 CFR 888.3810.