Clavicle Fixation System
FDA 510(k) clearance K254288 · decided 2026-03-23
Clearance details
- K-number
- K254288
- Device name
- Clavicle Fixation System
- Applicant
- Skeletal Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-31
- Decision date
- 2026-03-23
- Days to decision
- 82 days
- Clearance type
- Abbreviated
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.