Medpor Fixation System
FDA 510(k) K091807 · Porex Surgical, Inc.
510(k) numberK091807
Submission
- Device name
- Medpor Fixation System
- Applicant
- Porex Surgical, Inc.
Newnan, GA, US - Received
- June 18, 2009
- Decision date
- June 28, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|
| K102184 | Medpor Contain Can ImplantNPK · Traditional | 01/07/2011SE |
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| 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 |
Questions and answers
When was Medpor Fixation System cleared by the FDA?
Medpor Fixation System (K091807) received a 510(k) decision of Substantially Equivalent on June 28, 2010, 375 days after the submission was received.
What is the product code of K091807?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.