SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
FDA 510(k) clearance K152463 · decided 2016-01-20
Clearance details
- K-number
- K152463
- Device name
- SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
- Applicant
- Poriferous, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-08-28
- Decision date
- 2016-01-20
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Newnan, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.