OsteoCNX
FDA 510(k) clearance K223563 · decided 2023-01-25
Clearance details
- K-number
- K223563
- Device name
- OsteoCNX
- Applicant
- Converg Engineering
- Decision
- Substantially Equivalent
- Date received
- 2022-11-29
- Decision date
- 2023-01-25
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.