Bone Cement Genta, Bone Cement HV, Bone Cement LV
FDA 510(k) clearance K211163 · decided 2023-01-09
Clearance details
- K-number
- K211163
- Device name
- Bone Cement Genta, Bone Cement HV, Bone Cement LV
- Applicant
- Tecres S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2021-04-19
- Decision date
- 2023-01-09
- Days to decision
- 630 days
- Clearance type
- Traditional
- Product code
- LOD
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sommacampagna, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.