3S Hemi Toe
FDA 510(k) K072922 · Trilliant Surgical, Ltd.
510(k) numberK072922
Submission
- Device name
- 3S Hemi Toe
- Applicant
- Trilliant Surgical, Ltd.
Round Rock, TX, US - Received
- October 15, 2007
- Decision date
- November 28, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWD – Prosthesis, Toe, Hemi-, Phalangeal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3730
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250074 | HYALEX® MTP Hemiarthroplasty ImplantKWD · Traditional | Hyalex Orthopaedics, Inc. | 04/03/2026SE |
| K240268 | Accu-Joint Hemi ImplantKWD · Special | Accufix Surgical, Inc. | 02/29/2024SE |
| K221220 | Montross Extremity Medical Hemi Implant SystemKWD · Traditional | Montross Extremity Medical | 04/19/2023SE |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty ImplantKWD · Traditional | BioPoly, LLC | 11/22/2022SE |
| K201393 | restor3d MTP ImplantKWD · Traditional | Restor3D, Inc. | 05/25/2022SE |
| K203634 | BioPoly Great Toe Hemiarthroplasty ImplantKWD · Traditional | BioPoly, LLC | 02/02/2021SE |
| K200951 | Accu-Joint Hemi ImplantKWD · Traditional | Accufix Surgical, Inc. | 12/08/2020SE |
| K190261 | BOSS Toe Fixation SystemKWD · Traditional | Arthrosurface, Inc. | 08/14/2019SE |
| K190543 | Cannulated Hemi ImplantKWD · Traditional | Vilex IN Tennessee, Inc. | 05/31/2019SE |
| K161279 | Life Spine Metatarsal Hemi ImplantKWD · Traditional | Life Spine, Inc. | 02/01/2017SE |
More from Life Spine, Inc.
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|---|---|---|
| K212378 | Arsenal Ankle Plating SystemHRS · Traditional | 02/23/2022SE |
| K191009 | Arsenal Plating SystemHRS · Traditional | 08/12/2019SE |
| K181898 | Two-Step Implant SystemHWC · Traditional | 10/26/2018SE |
| K172405 | Sniper Staple System, Non-SterileJDR · Traditional | 12/11/2017SE |
| K172178 | Minimally Invasive Bunion Plating SystemHRS · Traditional | 11/16/2017SE |
| K162354 | Sniper Staple SystemJDR · Traditional | 04/20/2017SE |
| K160177 | Gridlock Ankle Plating SystemHRS · Traditional | 04/22/2016SE |
| K153338 | Tiger Cannulated Screw SystemHWC · Traditional | 01/14/2016SE |
| K130964 | Gridlock Plating SystemHRS · Special | 05/08/2013SE |
| K123525 | Gridlock Plating SystemHRS · Special | 02/15/2013SE |
Questions and answers
When was 3S Hemi Toe cleared by the FDA?
3S Hemi Toe (K072922) received a 510(k) decision of Substantially Equivalent on November 28, 2007, 44 days after the submission was received.
What is the product code of K072922?
The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.