Sbi Radio-Capitellar Implant
FDA 510(k) K060038 · Small Bone Innovations, Inc.
510(k) numberK060038
Submission
- Device name
- Sbi Radio-Capitellar Implant
- Applicant
- Small Bone Innovations, Inc.
New York, NY, US - Received
- January 6, 2006
- Decision date
- March 30, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDB – Prosthesis, Elbow, Semi-Constrained, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3160
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222807 | TEMA Elbow system - Line extensionJDB · Traditional | Lima Corporate S.P.A. | 10/26/2022SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 08/05/2020SE |
| K182461 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 12/27/2018SE |
| K171010 | Latitude EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 08/31/2017SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | Small Bone Innovations, Inc. | 12/20/2010SE |
| K100562 | Latitude Elbow ProsthesisJDB · Special | Tornier, Inc. | 06/29/2010SE |
| K070787 | Latitude Elbow ProthesisJDB · Special | Tornier | 08/24/2007SE |
| K070236 | Sbi Lateral Radio CapitellumJDB · Special | Small Bone Innovations, Inc. | 02/21/2007SE |
| K060438 | RHSJDB · Traditional | Tornier | 04/18/2006SE |
| K050848 | Tornier Elbow ProsthesisJDB · Traditional | Tornier | 07/14/2005SE |
More from Tornier
| 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 Radio-Capitellar Implant cleared by the FDA?
Sbi Radio-Capitellar Implant (K060038) received a 510(k) decision of Substantially Equivalent on March 30, 2006, 83 days after the submission was received.
What is the product code of K060038?
The FDA product code is JDB – Prosthesis, Elbow, Semi-Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3160.