Bonebridge Osteosynthesis Plating System
FDA 510(k) clearance K242399 · decided 2024-10-31
Clearance details
- K-number
- K242399
- Device name
- Bonebridge Osteosynthesis Plating System
- Applicant
- Bonebridge AG
- Decision
- Substantially Equivalent
- Date received
- 2024-08-13
- Decision date
- 2024-10-31
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Zug, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.