Small Bone Nailing System
FDA 510(k) K211439 · Skeletal Dynamics, Inc.
510(k) numberK211439
Submission
- Device name
- Small Bone Nailing System
- Applicant
- Skeletal Dynamics, Inc.
Miami, FL, US - Received
- May 10, 2021
- Decision date
- September 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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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 Small Bone Nailing System cleared by the FDA?
Small Bone Nailing System (K211439) received a 510(k) decision of Substantially Equivalent on September 30, 2021, 143 days after the submission was received.
What is the product code of K211439?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.