Data / Medical devices / United States / Poriferous, LLC
Poriferous, LLC: FDA-registered device maker in Newnan, GA, United States, 2 510(k) clearances
Poriferous, LLC is registered with the FDA (registration 3010781616) in Newnan, GA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 20, 2016. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3010781616
- Address
- 535 Pine RD Ste 206, Newnan, GA, United States, 30263
- Owner or operator
- Poriferous LLC (10046093)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 31, 2014
- Registered through
- 2027
- Brand names listed
- SU-POR Patient-Specific Cranial Implant, SU-POR Patient Specific Facial Implant, Su-Por Surgial Implant, Su-Por Surgical Cutting Guide
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Chin, Internal | FWP | 2 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 20, 2016 | K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | FWP | Substantially Equivalent | Poriferous, LLC | accessdata.fda.gov |
| June 13, 2014 | K140437 | SU-POR SURGICAL IMPLANT | KKY | Substantially Equivalent | Poriferous, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Prosthesis, Chin, Internal
- All makers of Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- All makers of Template
Updated January 20, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.