MTP Resesurfacing JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03
FDA 510(k) K003629 · Terray Corp.
510(k) numberK003629
Submission
- Device name
- MTP Resesurfacing JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03
- Applicant
- Terray Corp.
Arnprior, CA - Received
- November 24, 2000
- Decision date
- February 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K063275 | Distal Clavicular Fragment Immobilization Plate Left, Model 1810-116_126-03 (05,07)…HRS · Traditional | 07/27/2007SE |
| K003911 | Terray Stainless Steel Rod (Straight, L, Rectangle)KWP · Traditional | 03/13/2001SE |
| K974030 | Carpal Engaging Wrist Fusion PlateHRS · Traditional | 01/21/1998SE |
Questions and answers
When was MTP Resesurfacing JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 cleared by the FDA?
MTP Resesurfacing JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 (K003629) received a 510(k) decision of Substantially Equivalent on February 22, 2001, 90 days after the submission was received.
What is the product code of K003629?
The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.