Rhead Radial Head Extended Stems
FDA 510(k) K102180 · Small Bone Innovations, Inc.
510(k) numberK102180
Submission
- Device name
- Rhead Radial Head Extended Stems
- Applicant
- Small Bone Innovations, Inc.
Morrisville, PA, US - Received
- August 2, 2010
- Decision date
- December 20, 2010
- 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
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| K171010 | Latitude EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 08/31/2017SE |
| 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 |
| K060038 | Sbi Radio-Capitellar ImplantJDB · Traditional | Small Bone Innovations, Inc. | 03/30/2006SE |
| K050848 | Tornier Elbow ProsthesisJDB · Traditional | Tornier | 07/14/2005SE |
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Questions and answers
When was Rhead Radial Head Extended Stems cleared by the FDA?
Rhead Radial Head Extended Stems (K102180) received a 510(k) decision of Substantially Equivalent on December 20, 2010, 140 days after the submission was received.
What is the product code of K102180?
The FDA product code is JDB – Prosthesis, Elbow, Semi-Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3160.