Submission Details
| 510(k) Number | K221220 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 2022 |
| Decision Date | April 19, 2023 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Montross Extremity Medical Hemi Implant System
Apr 2023
Decision
357d
Days
Class 2
Risk
About This 510(k) Submission
K221220 is an FDA 510(k) clearance for the Montross Extremity Medical Hemi Implant System, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by Montross Extremity Medical (Colorado Springs, US). The FDA issued a Cleared decision on April 19, 2023, 357 days after receiving the submission on April 27, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.
Device Classification
| Product Code | KWD — Prosthesis, Toe, Hemi-, Phalangeal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3730 |
Manufacturer
Similar Devices — KWD Prosthesis, Toe, Hemi-, Phalangeal
All 44
K240268 · Accufix Surgical, Inc.
· Feb 2024
K222964 · BioPoly, LLC
· Nov 2022
K201393 · Restor3D, Inc.
· May 2022
K203634 · BioPoly, LLC
· Feb 2021
K200951 · Accufix Surgical, Inc.
· Dec 2020
K190261 · Arthrosurface, Inc.
· Aug 2019