Sutter Lesser Metatarsal Cap
FDA 510(k) K861983 · Sutter Biomedical, Inc.
510(k) numberK861983
Submission
- Device name
- Sutter Lesser Metatarsal Cap
- Applicant
- Sutter Biomedical, Inc.
San Diego, CA, US - Received
- May 22, 1986
- Decision date
- September 8, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K875249 | Sutter Phalangeal CapKWD · Traditional | 02/03/1988SE |
| K870200 | Sutter Finger Joint ProsthesisKYJ · Traditional | 10/09/1987SE |
| K850274 | Sutter CPM 9000 -Nonmeasuring Exercise EquipmentBXB · Traditional | 04/25/1985SE |
| K830974 | Sutter CPM 5000JFA · Traditional | 04/12/1983SE |
| K830649 | Sutter CPM 2000BXB · Traditional | 03/17/1983SE |
| K823539 | Sutter CPMBXB · Traditional | 01/14/1983SE |
| K820813 | Lesser Metatarsal Phalang. Joint ProsthKWH · Traditional | 05/21/1982SE |
| K820083 | Sutter CPMBXB · Traditional | 01/28/1982SE |
| K812691 | Silicone ImplantsMDM · Traditional | 11/16/1981SE |
| K802342 | Proximal Interphalangeal Joint ImplantJDI · Traditional | 10/14/1981SE |
Questions and answers
When was Sutter Lesser Metatarsal Cap cleared by the FDA?
Sutter Lesser Metatarsal Cap (K861983) received a 510(k) decision of Substantially Equivalent on September 8, 1986, 109 days after the submission was received.
What is the product code of K861983?
The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.