Small Bone Fixation System
FDA 510(k) K033406 · Hand Innovations, Inc.
510(k) numberK033406
Submission
- Device name
- Small Bone Fixation System
- Applicant
- Hand Innovations, Inc.
Miami, FL, US - Received
- October 24, 2003
- Decision date
- January 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K061748 | Fragment Plate SystemKTT · Special | 07/17/2006SE |
| K060864 | Multidirectional Threaded PegLXT · Special | 04/28/2006SE |
| K060294 | Diaphyseal PlateHRS · Traditional | 03/22/2006SE |
| K060290 | Shoulder Fixation SystemLXT · Special | 02/27/2006SE |
| K052294 | Shoulder Nail PlateHRS · Traditional | 10/21/2005SE |
| K052248 | Dorsal Nail Plate, AnatomicalHRS · Special | 09/14/2005SE |
| K051728 | Modification to Shoulder Fixation SystemLXT · Special | 07/20/2005SE |
| K050932 | Distal Volar Radius Anatomical Plate SystemLXT · Special | 04/26/2005SE |
| K042059 | Shoulder Fixation SystemLXT · Traditional | 09/30/2004SE |
| K041157 | Modification to Small Bone Fixation SystemHTY · Traditional | 07/30/2004SE |
Questions and answers
When was Small Bone Fixation System cleared by the FDA?
Small Bone Fixation System (K033406) received a 510(k) decision of Substantially Equivalent on January 15, 2004, 83 days after the submission was received.
What is the product code of K033406?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.