APTUS Clavicle System 2.8
FDA 510(k) clearance K260761 · decided 2026-06-05
Clearance details
- K-number
- K260761
- Device name
- APTUS Clavicle System 2.8
- Applicant
- Medartis AG
- Decision
- Substantially Equivalent
- Date received
- 2026-03-09
- Decision date
- 2026-06-05
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Basel, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.