GXP — Methyl Methacrylate For Cranioplasty Class II
FDA product code GXP covers "Methyl Methacrylate For Cranioplasty", a Class II medical device regulated under 21 CFR 882.5300. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXP
- Device Class
- Class II
- Regulation Number
- 882.5300
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261265 | orthocon | Permatage XT Settable Bone Putty | June 15, 2026 |
| K253732 | orthocon | Permatage Flowable, Settable Bone Paste | March 13, 2026 |
| K253854 | orthocon | MONTAGE XT Cranial Cement | January 2, 2026 |
| K241027 | orthocon | Permatage Settable Bone Putty | September 26, 2024 |
| K232771 | orthocon | Montage Flowable Settable, Resorbable Bone Paste | February 16, 2024 |
| K231475 | orthocon | MONTAGE-QS Settable, Resorbable Bone Putty | October 12, 2023 |
| K221933 | orthocon | MONTAGE Settable, Resorbable Bone Putty | January 13, 2023 |
| K182742 | dimensional bioceramics | DB-CMF | June 20, 2019 |
| K162864 | skeletal kinetics | OsteoVation Impact | January 13, 2017 |
| K143661 | stryker | DirectInject | September 2, 2015 |
| K102018 | synthes usa products | NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY | September 23, 2010 |
| K091382 | doctors research group | KRYPTONITE BONE CEMENT | November 16, 2009 |
| K070012 | kyung won medical co | POLYBONE | December 27, 2007 |
| K072601 | osteosymbionics | OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT | December 10, 2007 |
| K071791 | codman and shurtleff | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 | July 30, 2007 |
| K060763 | stryker | STRYKER INJECTABLE CEMENT | September 22, 2006 |
| K060445 | synthes (usa) | NORIAN CRS BONE CEMENT | April 13, 2006 |
| K060443 | synthes (usa) | NORIAN CRS FAST SET PUTTY | April 13, 2006 |
| K051093 | osteopore | OSTEOPORE PCL SCAFFOLD | March 17, 2006 |
| K051784 | skeletal kinetics | OSTEOVATION CMF BONE VOID FILLER | July 20, 2005 |