Porex Surgical, Inc.
Medical device manufacturer in Newnan, GA.
19510(k) clearances
0PMA approvals
1recalls
Device types
- HPZ Implant, Eye Sphere 6
- FWP Prosthesis, Chin, Internal 2
- NPK Barrier, Synthetic, Intraoral 2
- HQN Conformer, Ophthalmic 1
- LYA Splint, Intranasal Septal 1
- GXP Methyl Methacrylate For Cranioplasty 1
- OKS Lacrimal Stents And Intubation Sets 1
- FTM Mesh, Surgical 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- JOF Polymer, Ent Synthetic, Porous Polyethylene 1
- JEY Plate, Bone 1
- HBW Fastener, Plate, Cranioplasty 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K102184 | Medpor Contain Can ImplantNPK · Traditional | 01/07/2011SE |
| K101835 | Medpor Fixation System-Cranial, Models 80080, 80079HBW · Traditional | 12/03/2010SE |
| K091807 | Medpor Fixation SystemJEY · Traditional | 06/28/2010SE |
| K091120 | Medpor Contain ImplantNPK · Traditional | 03/19/2010SE |
| K083621 | Medpor Customized Surgical ImplantJOF · Traditional | 02/03/2009SE |
| K071335 | Medpor Attractor ImplantHPZ · Traditional | 08/08/2007SE |
| K052297 | Porex Electrosurgery NeedleGEI · Traditional | 03/28/2006SE |
| K040851 | Medpor Attractor Magnetic Coupling SystemHPZ · Traditional | 07/16/2004SE |
| K040364 | Medpor Craniofacial Implants with Embedded Titanium MeshFTM · Traditional | 06/30/2004SE |
| K021357 | Medpor Plus Orbital Volume Replacement ImpantHPZ · Traditional | 08/05/2002SE |
| K012350 | Medpor Plus Surgical Implant BiomaterialFWP · Traditional | 03/14/2002SE |
| K012108 | Medpor Coated Tear DrainOKS · Traditional | 12/19/2001SE |
| K010902 | Medpor Quad Motility ImplantHPZ · Traditional | 06/19/2001SE |
| K982040 | Medpor Surgical Granule ImplantsGXP · Traditional | 09/08/1998SE |
| K981374 | Porex Nostril RetainersLYA · Traditional | 07/02/1998SE |
| K972034 | Medpor Ocular ConformerHQN · Traditional | 01/20/1998SE |
| K954939 | Medpor Ocular Screw & AccessoriesHPZ · Traditional | 01/25/1996SE |
| K952677 | Medpor Barrier Surgical Implant BiomaterialFWP · Traditional | 08/21/1995SE |
| K943275 | Medpor Surgical Implant MaterialHPZ · Traditional | 09/02/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2302-2008 | Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The…The Ocular Conformers were distributed with an expired expiration date. | 03/28/2008Terminated |