Sbi Ulnar Head Implant
FDA 510(k) K061146 · Small Bone Innovations, Inc.
510(k) numberK061146
Submission
- Device name
- Sbi Ulnar Head Implant
- Applicant
- Small Bone Innovations, Inc.
New York, NY, US - Received
- April 25, 2006
- Decision date
- July 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| 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 |
|---|---|---|
| K130147 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)HSB · Special | 05/03/2013SE |
| K112982 | Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail )HSB · Traditional | 04/02/2012SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | 12/20/2010SE |
| K092754 | Sbi Foot and Ankle Cannulated Screw System, Model 100-0061HWC · Traditional | 01/19/2010SE |
| K093550 | Mini Rail External Fixator SystemKTT · Special | 01/07/2010SE |
| K073635 | Sbi SR MTP Toe ImplantKWD · Traditional | 03/19/2008SE |
| K071541 | Sbi TwistofixHWC · Traditional | 09/10/2007SE |
| K063635 | Sbi Forefoot SetHWC · Traditional | 08/29/2007SE |
| K071656 | Sbi ArtfixHWC · Traditional | 08/27/2007SE |
| K071540 | Sbi Titanium Threaded PinJDW · Traditional | 08/08/2007SE |
Questions and answers
When was Sbi Ulnar Head Implant cleared by the FDA?
Sbi Ulnar Head Implant (K061146) received a 510(k) decision of Substantially Equivalent on July 19, 2006, 85 days after the submission was received.
What is the product code of K061146?
The FDA product code is KXE – Prosthesis, Wrist, Hemi-, Ulnar, a Class II (moderate risk) device regulated under 21 CFR 888.3810.