Medpor Surgical Granule Implants
FDA 510(k) K982040 · Porex Surgical, Inc.
510(k) numberK982040
Submission
- Device name
- Medpor Surgical Granule Implants
- Applicant
- Porex Surgical, Inc.
College Park, GA, US - Received
- June 10, 1998
- Decision date
- September 8, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K251959 | TnR Cranial ImplantGXP · Traditional | T&R BIOFAB CO., Ltd. | 07/30/2026SE |
| K261265 | Permatage XT Settable Bone PuttyGXP · Special | Orthocon, Inc. | 06/15/2026SE |
| K253732 | Permatage Flowable, Settable Bone PasteGXP · Traditional | Orthocon, Inc. | 03/13/2026SE |
| K253854 | MONTAGE XT Cranial CementGXP · Special | Orthocon, Inc. | 01/02/2026SE |
| K241027 | Permatage Settable Bone PuttyGXP · Traditional | Orthocon, Inc. | 09/26/2024SE |
| K232771 | Montage Flowable Settable, Resorbable Bone PasteGXP · Traditional | Orthocon, Inc. | 02/16/2024SE |
| K231475 | MONTAGE-QS Settable, Resorbable Bone PuttyGXP · Traditional | Orthocon, Inc. | 10/12/2023SE |
| K221933 | MONTAGE Settable, Resorbable Bone PuttyGXP · Traditional | Orthocon, Inc. | 01/13/2023SE |
| K182742 | Db-CmfGXP · Traditional | Dimensional Bioceramics, LLC | 06/20/2019SE |
| K162864 | OsteoVation ImpactGXP · Traditional | Skeletal Kinetics, LLC | 01/13/2017SE |
More from Skeletal Kinetics, LLC
| 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 |
Questions and answers
When was Medpor Surgical Granule Implants cleared by the FDA?
Medpor Surgical Granule Implants (K982040) received a 510(k) decision of Substantially Equivalent on September 8, 1998, 90 days after the submission was received.
What is the product code of K982040?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.