Medpor Attractor Implant
FDA 510(k) K071335 · Porex Surgical, Inc.
510(k) numberK071335
Submission
- Device name
- Medpor Attractor Implant
- Applicant
- Porex Surgical, Inc.
Newnan, GA, US - Received
- May 11, 2007
- Decision date
- August 8, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HPZ – Implant, Eye Sphere
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code HPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212741 | EzyporHPZ · Traditional | Fci (France Chirurgie Instrumentation) Sas | 06/24/2022SE |
| K123764 | Durette Ocular ImplantHPZ · Traditional | Oculo-Plastik, Inc. | 01/31/2013SE |
| K110554 | Bioceramic Orbital Implant, OrbtexHPZ · Traditional | Ceramisys, Ltd. | 11/02/2011SE |
| K112176 | Silicone SpheresHPZ · Special | Oculo Plastik, Inc. | 09/15/2011SE |
| K083342 | Orbital Reconstructive Implant IIHPZ · Traditional | Evera Medical, Inc. | 03/12/2009SE |
| K082850 | Eye SpheresHPZ · Traditional | Product and Educational Services, LLC | 02/27/2009SE |
| K073293 | Durette ImplantHPZ · Traditional | Oculo Plastik, Inc. | 03/19/2008SE |
| K070130 | Orbital Reconstructive ImplantHPZ · Traditional | Becker & Associates Consulting, Inc. | 04/19/2007SE |
| K053298 | Alphasphere Orbital ImplantHPZ · Traditional | Hydron Pty Limited | 05/09/2006SE |
| K040851 | Medpor Attractor Magnetic Coupling SystemHPZ · Traditional | Porex Surgical, Inc. | 07/16/2004SE |
More from Porex Surgical, Inc.
| 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 |
| 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 |
Questions and answers
When was Medpor Attractor Implant cleared by the FDA?
Medpor Attractor Implant (K071335) received a 510(k) decision of Substantially Equivalent on August 8, 2007, 89 days after the submission was received.
What is the product code of K071335?
The FDA product code is HPZ – Implant, Eye Sphere, a Class II (moderate risk) device regulated under 21 CFR 886.3320.