Submission Details
| 510(k) Number | K222665 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 06, 2022 |
| Decision Date | January 25, 2023 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Medline UNITE? Ankle Fusion Plating System
Jan 2023
Decision
141d
Days
Class 2
Risk
About This 510(k) Submission
K222665 is an FDA 510(k) clearance for the Medline UNITE? Ankle Fusion Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on January 25, 2023, 141 days after receiving the submission on September 6, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.
Device Classification
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
Manufacturer
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