Orthropro Hemi Toe
FDA 510(k) K062908 · Orthopro, LLC
510(k) numberK062908
Submission
- Device name
- Orthropro Hemi Toe
- Applicant
- Orthopro, LLC
Round Rock, TX, US - Received
- September 27, 2006
- Decision date
- November 13, 2006
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K122936 | Ankle Trauma SystemHRS · Traditional | 02/28/2013SE |
| K113006 | I-Fuse Hammer Toe SystemsHWC · Traditional | 05/25/2012SE |
| K093055 | CSTS ScrewHWC · Traditional | 11/22/2010SE |
| K073228 | DC Ulnar Shortening SystemHRS · Traditional | 02/29/2008SE |
| K070555 | Orthopro Steinman Pins and Kirschner WiresHTY · Traditional | 07/13/2007SE |
| K071243 | Metal Hemi ImplantKWD · Special | 05/23/2007SE |
Questions and answers
When was Orthropro Hemi Toe cleared by the FDA?
Orthropro Hemi Toe (K062908) received a 510(k) decision of Substantially Equivalent on November 13, 2006, 47 days after the submission was received.
What is the product code of K062908?
The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.