Submission Details
| 510(k) Number | K240268 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 31, 2024 |
| Decision Date | February 29, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Special
Accu-Joint Hemi Implant
Feb 2024
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K240268 is an FDA 510(k) clearance for the Accu-Joint Hemi Implant, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by Accufix Surgical, Inc. (West Haven, US). The FDA issued a Cleared decision on February 29, 2024, 29 days after receiving the submission on January 31, 2024. 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
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