First Choice Druj System, Partial Head Implant
FDA 510(k) K112481 · Ascension Orthopedic
510(k) numberK112481
Submission
- Device name
- First Choice Druj System, Partial Head Implant
- Applicant
- Ascension Orthopedic
Austin, TX, US - Received
- August 29, 2011
- Decision date
- April 9, 2012
- 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
Other 510(k)s with product code KXE
| 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 |
| 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 |
| K052137 | Ascension MuhKXE · Traditional | Ascension Orthopedics, Inc. | 11/03/2005SE |
| 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 |
|---|---|---|
| K140463 | Integra External Fixation SystemKTT · Traditional | 10/10/2014SE |
| K131360 | Integra Titanium Bone WedgeHRS · Traditional | 08/07/2013SE |
| K130050 | Titan Reverse Shoulder SystemKWS · Traditional | 06/18/2013SE |
| K112438 | Titan Modular Total Shoulder SystemKWS · Special | 04/11/2012SE |
| K112278 | Ascension Nugrip CMC ImplantKYI · Traditional | 11/04/2011SE |
| K111799 | Nugait(Tm) Subtalar Implant SystemHWC · Traditional | 08/19/2011SE |
Questions and answers
When was First Choice Druj System, Partial Head Implant cleared by the FDA?
First Choice Druj System, Partial Head Implant (K112481) received a 510(k) decision of Substantially Equivalent on April 9, 2012, 224 days after the submission was received.
What is the product code of K112481?
The FDA product code is KXE – Prosthesis, Wrist, Hemi-, Ulnar, a Class II (moderate risk) device regulated under 21 CFR 888.3810.