CustomizedBone Service
FDA 510(k) clearance K160707 · decided 2016-12-17
Clearance details
- K-number
- K160707
- Device name
- CustomizedBone Service
- Applicant
- Fin-Ceramica Faenza S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-14
- Decision date
- 2016-12-17
- Days to decision
- 278 days
- Clearance type
- Traditional
- Product code
- GXN
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Faenza, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.