External Fixation Bone Distractor — Paragon 28, Inc. (510(k) K251862)
External Fixation Bone Distractor — Paragon 28, Inc. (510(k) K251862) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: External Fixation Bone Distractor; Applicant: Paragon 28, Inc.; Clearance track: 510(k).
| Device name | External Fixation Bone Distractor |
|---|---|
| Applicant | Paragon 28, Inc. |
| Clearance track | 510(k) |
| Submission number | K251862 |
| Decision | Substantially Equivalent |
| Decision date | 2025-08-11 |
| Date received | 2025-06-17 |
| Product code | KTT |
| Device class | 2 |
| Medical specialty | Orthopedic |
| Applicant location | CO, US |
| Source | openFDA device |
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