GREAT TOE IMPLANT
FDA 510(k) clearance K021063 · decided 2002-07-01
Clearance details
- K-number
- K021063
- Device name
- GREAT TOE IMPLANT
- Applicant
- Signal Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-02
- Decision date
- 2002-07-01
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KWD
- Device class
- 2
- Regulation number
- 888.3730
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Port Huron, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HYALEX® MTP Hemiarthroplasty Implant (K250074) | Hyalex Orthopaedics, Inc. | 2026-04-03 |
| Accu-Joint Hemi Implant (K240268) | Accufix Surgical, Inc. | 2024-02-29 |
| Montross Extremity Medical Hemi Implant System (K221220) | Montross Extremity Medical | 2023-04-19 |
| BioPoly Lesser Toe Hemiarthroplasty Implant (K222964) | BioPoly, LLC | 2022-11-22 |
| restor3d MTP Implant (K201393) | Restor3D, Inc. | 2022-05-25 |
| BioPoly Great Toe Hemiarthroplasty Implant (K203634) | BioPoly, LLC | 2021-02-02 |
| Accu-Joint Hemi Implant (K200951) | Accufix Surgical, Inc. | 2020-12-08 |
| BOSS Toe Fixation System (K190261) | Arthrosurface, Inc. | 2019-08-14 |
| Cannulated Hemi Implant (K190543) | Vilex IN Tennessee, Inc. | 2019-05-31 |
| Life Spine Metatarsal Hemi Implant (K161279) | Life Spine, Inc. | 2017-02-01 |
| HemiCAP MTP Resurfacing Hemi-Arthroplasty System (K152454) | Arthrosurface, Inc. | 2016-04-11 |
| HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT (K131377) | Arthrosurface, Inc. | 2013-11-19 |
Recalls involving this device
No recalls on record reference this clearance.