Genostis Osteosynthesis System
FDA 510(k) clearance K242988 · decided 2025-06-27
Clearance details
- K-number
- K242988
- Device name
- Genostis Osteosynthesis System
- Applicant
- Genostis AF
- Decision
- Substantially Equivalent
- Date received
- 2024-09-26
- Decision date
- 2025-06-27
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Burgdorf, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.