External Fixation Bone Distractor
FDA 510(k) clearance K251862 · decided 2025-08-11
Clearance details
- K-number
- K251862
- Device name
- External Fixation Bone Distractor
- Applicant
- Paragon 28, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-17
- Decision date
- 2025-08-11
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.