Fragment Plate System, Screws, Pins and K-Wires
FDA 510(k) K041081 · Hand Innovations, Inc.
510(k) numberK041081
Submission
- Device name
- Fragment Plate System, Screws, Pins and K-Wires
- Applicant
- Hand Innovations, Inc.
Miami, FL, US - Received
- April 26, 2004
- Decision date
- July 1, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 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 Fragment Plate System, Screws, Pins and K-Wires cleared by the FDA?
Fragment Plate System, Screws, Pins and K-Wires (K041081) received a 510(k) decision of Substantially Equivalent on July 1, 2004, 66 days after the submission was received.
What is the product code of K041081?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.