Porex Surgical, Inc.
Newnan, GA, US
Porex Surgical, Inc. appears in FDA device records in Newnan, GA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Porex Surgical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Howmedica Osteonics Corp dba Stryker Craniomaxillofacialrecall
510(k) clearance history
FDA records hold 19 510(k) clearances for Porex Surgical, Inc. between 1994 and 2011. The busiest year on record is 1998, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 3 |
| 2001 | 2 |
| 2002 | 2 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102184 | MEDPOR CONTAIN CAN IMPLANT | NPK | Substantially Equivalent | |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | HBW | Substantially Equivalent | |
| K091807 | MEDPOR FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K091120 | MEDPOR CONTAIN IMPLANT | NPK | Substantially Equivalent | |
| K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | JOF | Substantially Equivalent | |
| K071335 | MEDPOR ATTRACTOR IMPLANT | HPZ | Substantially Equivalent | |
| K052297 | POREX ELECTROSURGERY NEEDLE | GEI | Substantially Equivalent | |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | HPZ | Substantially Equivalent | |
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH | FTM | Substantially Equivalent | |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | HPZ | Substantially Equivalent | |
| K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | FWP | Substantially Equivalent | |
| K012108 | MEDPOR COATED TEAR DRAIN | OKS | Substantially Equivalent | |
| K010902 | MEDPOR QUAD MOTILITY IMPLANT | HPZ | Substantially Equivalent | |
| K982040 | MEDPOR SURGICAL GRANULE IMPLANTS | GXP | Substantially Equivalent | |
| K981374 | POREX NOSTRIL RETAINERS | LYA | Substantially Equivalent | |
| K972034 | MEDPOR OCULAR CONFORMER | HQN | Substantially Equivalent | |
| K954939 | MEDPOR OCULAR SCREW & ACCESSORIES | HPZ | Substantially Equivalent | |
| K952677 | MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL | FWP | Substantially Equivalent | |
| K943275 | MEDPOR SURGICAL IMPLANT MATERIAL | HPZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- NPKBarrier, Synthetic, Intraoral
- HQNConformer, Ophthalmic
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HBWFastener, Plate, Cranioplasty
- HPZImplant, Eye Sphere
- OKSLacrimal Stents And Intubation Sets
- FTMMesh, Surgical
- GXPMethyl Methacrylate For Cranioplasty
- JEYPlate, Bone
- JOFPolymer, Ent Synthetic, Porous Polyethylene
- FWPProsthesis, Chin, Internal
- LYASplint, Intranasal Septal
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1435-2012 | MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe. | The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe. | Terminated | ||
| Z-0922-2012 | MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. | The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch. | Terminated | ||
| Z-2302-2008 | Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process. | The Ocular Conformers were distributed with an expired expiration date. | Terminated | ||
| Z-1515-06 | Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA. | Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material | Terminated | ||
| Z-0712-05 | MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA | The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain