Wrist Arthrodesis Nail System
FDA 510(k) K092720 · Skeletal Dynamics, LLC
510(k) numberK092720
Submission
- Device name
- Wrist Arthrodesis Nail System
- Applicant
- Skeletal Dynamics, LLC
Shelton, CT, US - Received
- September 4, 2009
- Decision date
- June 29, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
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| K261770 | Suture Button Repair SystemMBI · Traditional | 07/29/2026SE |
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| K252949 | Geminus Volar Distal Radius Plating SystemHRS · Traditional | 11/13/2025SE |
| K242436 | Proximal Humerus Fixation SystemHRS · Traditional | 11/14/2024SE |
| K243381 | Total Wrist Arthroplasty System (TWA)JWJ · Special | 11/01/2024SE |
| K241815 | Protean Fragment Plating SystemHRS · Traditional | 09/26/2024SE |
| K242055 | Freefix Forearm Plating SystemHRS · Special | 08/01/2024SE |
| K240835 | Suture Button Repair SystemMBI · Traditional | 07/19/2024SE |
| K233574 | Total Wrist Arthroplasty System (TWA)JWJ · Traditional | 07/03/2024SE |
| K231447 | Double Internal Joint Stabilizer- ElbowOZI · Traditional | 12/15/2023SE |
Questions and answers
When was Wrist Arthrodesis Nail System cleared by the FDA?
Wrist Arthrodesis Nail System (K092720) received a 510(k) decision of Substantially Equivalent on June 29, 2010, 298 days after the submission was received.
What is the product code of K092720?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.