GXP — Methyl Methacrylate For Cranioplasty Class II
FDA Device Classification
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 |
|---|
| 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 |
| K043334 | stryker instruments | BONE SOURCE HAC RAPID SETTING CEMENT | February 9, 2005 |