Soribie Resurfacing Total Elbow System (Proposed Name)
FDA 510(k) K960087 · Wrightmedicaltechnologyinc
510(k) numberK960087
Submission
- Device name
- Soribie Resurfacing Total Elbow System (Proposed Name)
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- January 11, 1996
- Decision date
- September 20, 1996
- 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 |
| K060038 | Sbi Radio-Capitellar ImplantJDB · Traditional | Small Bone Innovations, Inc. | 03/30/2006SE |
More from Small Bone Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment SystemHSN · Traditional | 01/27/2023SE |
| K213342 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 01/05/2022SE |
| K212996 | Sterile PHALINX Hammertoe SystemHWC · Traditional | 11/16/2021SE |
| K202815 | PROPHECY Preoperative Navigation Alignment SystemHSN · Traditional | 03/10/2021SE |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemHRS · Traditional | 01/08/2021SE |
| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle SystemHSN · Traditional | 08/22/2019SE |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) SystemHWC · Traditional | 08/13/2019SE |
| K183620 | PROSTEP TBC Implant SystemHRS · Traditional | 06/06/2019SE |
Questions and answers
When was Soribie Resurfacing Total Elbow System (Proposed Name) cleared by the FDA?
Soribie Resurfacing Total Elbow System (Proposed Name) (K960087) received a 510(k) decision of Substantially Equivalent on September 20, 1996, 253 days after the submission was received.
What is the product code of K960087?
The FDA product code is JDB – Prosthesis, Elbow, Semi-Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3160.